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Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)

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ClinicalTrials.gov Identifier: NCT02990338
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Results First Posted : December 6, 2019
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plasma Cell Myeloma
Interventions Drug: Isatuximab
Drug: Pomalidomide
Drug: Dexamethasone
Enrollment 307
Recruitment Details The study was conducted at 102 sites in 24 countries. A total of 387 participants were screened between 22 December 2016 and 01 February 2018. Out of which, 307 participants were randomized in 1:1 ratio to IPd (Isatuximab + Pomalidomide + Dexamethasone) and Pd (Pomalidomide + Dexamethasone) arms using an interactive response technology (IRT).
Pre-assignment Details Randomization was stratified by age (less than [<] 75 years versus greater than and equal to [>=] 75 years) and number of previous lines of therapy (2 or 3 versus more than 3). Results are reported based on the primary completion date of 22 November 2018.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks). Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Period Title: Overall Study
Started 153 154
Treated 149 152
Ongoing 35 65
Completed 35 65
Not Completed 118 89
Reason Not Completed
Adverse Event             19             11
Progressive disease             88             66
Poor compliance to protocol             0             1
Withdrawal by Subject             6             5
Other             1             4
Randomized but not treated             4             2
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone) Total
Hide Arm/Group Description Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks). Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks). Total of all reporting groups
Overall Number of Baseline Participants 153 154 307
Hide Baseline Analysis Population Description
Analysis was performed on randomized population which included all participants with a signed informed consent and have been allocated a randomization number by the IRT, regardless of whether the participants was treated or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 154 participants 307 participants
65.2  (9.5) 66.6  (9.1) 65.9  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 154 participants 307 participants
Female
83
  54.2%
65
  42.2%
148
  48.2%
Male
70
  45.8%
89
  57.8%
159
  51.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 154 participants 307 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
15
   9.8%
21
  13.6%
36
  11.7%
Native Hawaiian or Other Pacific Islander
1
   0.7%
2
   1.3%
3
   1.0%
Black or African American
3
   2.0%
1
   0.6%
4
   1.3%
White
126
  82.4%
118
  76.6%
244
  79.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   5.2%
12
   7.8%
20
   6.5%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of >=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >=0.5gram(g)/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24hour), appearance of new lesion(s),>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis.
Time Frame From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Median (95% Confidence Interval)
Unit of Measure: months
6.47
(4.468 to 8.279)
11.53
(8.936 to 13.897)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pd (Pomalidomide + Dexamethasone), IPd (Isatuximab + Pomalidomide + Dexamethasone)
Comments Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Type of Statistical Test Superiority
Comments A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
Statistical Test of Hypothesis P-Value 0.0010
Comments One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.
Method Log Rank
Comments Stratification was based on age (<75 years versus >=75 years) and number of previous lines of therapy (2 or 3 versus >3) according to IRT.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.596
Confidence Interval (2-Sided) 95%
0.436 to 0.814
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate (ORR): Percentage of Participants With Overall Response
Hide Description ORR:percentage of participants with stringent complete response(sCR), complete response(CR), very good partial response(VGPR), and partial response(PR) as best overall response, assessed by IRC using IMWG criteria. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h,if present at baseline,>=50% reduction in the size(SPD) of soft tissue plasmacytomas.
Time Frame From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Measure Type: Number
Unit of Measure: percentage of participants
35.3 60.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pd (Pomalidomide + Dexamethasone), IPd (Isatuximab + Pomalidomide + Dexamethasone)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance at 0.025.
Method Cochran-Mantel-Haenszel
Comments One sided p-value was stratified based on age (<75 years versus >=75 years) and number of previous lines (2 or 3 versus >3) according to IRT.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first.
Time Frame From the date of randomization to date of death from any cause or study cut-off date, whichever was earlier (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(13.897 to NA)
NA [2] 
(NA to NA)
[1]
Due to smaller number of participants with an event, median and 95% Confidence Interval (CI) could not be calculated.
[2]
Due to smaller number of participants with an event, median and 95% CI could not be calculated.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pd (Pomalidomide + Dexamethasone), IPd (Isatuximab + Pomalidomide + Dexamethasone)
Comments CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.
Type of Statistical Test Superiority
Comments A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
Statistical Test of Hypothesis P-Value 0.0631
Comments One-sided significance level was 0.0008 using the O'Brien-Fleming alpha spending function.
Method Log Rank
Comments Stratified on age (<75 years versus >=75 years) and number of previous lines of therapy (2 or 3 versus > 3) according to IRT.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.687
Confidence Interval (2-Sided) 95%
0.461 to 1.023
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of >= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >= 0.5 g/dL), serum M-protein increase >=1 g/dL if the lowest M component was >=5 g/dL; urine M-component (the absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis.
Time Frame From the date of randomization to the date of first documentation of progression, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Median (95% Confidence Interval)
Unit of Measure: months
7.75
(5.027 to 9.758)
12.71
(11.203 to 15.211)
5.Secondary Outcome
Title Progression Free Survival in High Risk Cytogenetic Population
Hide Description PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1 g/dL if lowest M component was >=5 g/dL; urine M-component (absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 centimeter (cm) in short axis.
Time Frame From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed in high-risk cytogenetic population which included participants carrying del (17p), t(4;14) or t(14;16) in each arm.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 36 25
Median (95% Confidence Interval)
Unit of Measure: months
3.745
(2.793 to 7.885)
7.491 [1] 
(2.628 to NA)
[1]
Due to smaller number of participants with an event, 95% CI could not be calculated.
6.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL;urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion,or >=50% increase in the longest diameter of a previous lesion >1 cm in short axis. PR:>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h.
Time Frame From the date of the first IRC determined response to the date of first IRC progression or death, whichever occurred first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on responders in ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 54 93
Median (95% Confidence Interval)
Unit of Measure: months
11.07 [1] 
(8.542 to NA)
13.27 [1] 
(10.612 to NA)
[1]
Due to smaller number of participants with an event, 95% CI could not be calculated.
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect, is a medically important event.
Time Frame From randomization up to 30 days after last dose of study drug (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population which included all participants from the ITT population who received at least one dose or a part of a dose of the study treatments.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 149 152
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
146
  98.0%
151
  99.3%
Any treatment emergent SAE
80
  53.7%
94
  61.8%
Any TEAE leading to treatment discontinuation
19
  12.8%
11
   7.2%
8.Secondary Outcome
Title Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)
Hide Description CEOI was defined as the plasma concentration at end of infusion.
Time Frame End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 149
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per milliliter (mcg/mL)
End of infusion: C1D1 Number Analyzed 141 participants
163.05
(34.528%)
End of infusion: C1D15 Number Analyzed 120 participants
269.20
(32.622%)
End of infusion: C2D1 Number Analyzed 134 participants
299.85
(35.921%)
End of infusion: C4D1 Number Analyzed 117 participants
279.31
(47.555%)
9.Secondary Outcome
Title Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)
Hide Description Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.
Time Frame End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 149
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
C2D1 versus C1D1 Number Analyzed 130 participants
1.860
(170.9185%)
C4D1 versus C1D1 Number Analyzed 112 participants
1.777
(224.2542%)
10.Secondary Outcome
Title Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)
Hide Description CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.
Time Frame Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 149
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
C1D1 Number Analyzed 140 participants
171.55
(38.299%)
C4D1 Number Analyzed 114 participants
294.96
(57.331%)
11.Secondary Outcome
Title PK Parameter: Plasma Concentration of Isatuximab at Ctrough
Hide Description Trough Concentration (Ctrough) is the concentration prior to study drug administration.
Time Frame Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT[30 days after last drug administration])
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Hide Analysis Population Description
Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title IPd (Isatuximab + Pomalidomide + Dexamethasone)
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Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 149
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
C1D1 Number Analyzed 144 participants
0.00
(1194.973%)
C1D8 Number Analyzed 135 participants
31.49
(53.602%)
C1D15 Number Analyzed 126 participants
57.89
(54.764%)
C1D22 Number Analyzed 126 participants
84.82
(57.666%)
C2D1 Number Analyzed 138 participants
89.09
(60.155%)
C2D15 Number Analyzed 121 participants
89.35
(61.167%)
C3D1 Number Analyzed 131 participants
64.15
(76.469%)
C3D15 Number Analyzed 109 participants
91.73
(78.406%)
C4D1 Number Analyzed 118 participants
86.05
(70.062%)
C4D15 Number Analyzed 108 participants
105.42
(68.035%)
C5D1 Number Analyzed 108 participants
106.08
(65.275%)
C6D1 Number Analyzed 107 participants
111.33
(64.985%)
C7D1 Number Analyzed 96 participants
134.14
(60.017%)
C8D1 Number Analyzed 86 participants
146.15
(55.946%)
C9D1 Number Analyzed 82 participants
162.84
(65.193%)
C10D1 Number Analyzed 73 participants
145.86
(60.719%)
C11D1 Number Analyzed 71 participants
169.39
(56.078%)
C12D1 Number Analyzed 63 participants
182.32
(56.814%)
C13D1 Number Analyzed 49 participants
215.85
(54.667%)
C14D1 Number Analyzed 35 participants
214.88
(55.172%)
C15D1 Number Analyzed 24 participants
253.61
(58.885%)
C16D1 Number Analyzed 19 participants
206.60
(50.965%)
C17D1 Number Analyzed 13 participants
242.79
(45.364%)
C18D1 Number Analyzed 8 participants
216.70
(58.273%)
C19D1 Number Analyzed 5 participants
240.36
(42.099%)
C20D1 Number Analyzed 1 participants
164.07
EOT Number Analyzed 60 participants
9.51
(136.883%)
12.Secondary Outcome
Title PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)
Hide Description Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.
Time Frame Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1
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Hide Analysis Population Description
Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 149
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
C2D1 versus C1D8 Number Analyzed 125 participants
2.689
(734.5547%)
C4D1 versus C1D8 Number Analyzed 108 participants
2.620
(645.4171%)
13.Secondary Outcome
Title Number of Participants With Anti-drug Antibodies (ADA)
Hide Description ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.
Time Frame From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)
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Hide Analysis Population Description
Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IPd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result.
Arm/Group Title IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 151
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-existing ADA
0
   0.0%
Treatment induced ADA
0
   0.0%
Treatment boosted ADA
0
   0.0%
14.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score
Hide Description EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
Time Frame Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
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Hide Analysis Population Description
Analysis was performed on safety population evaluable for global health status. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
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Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 134 139
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 134 participants 137 participants
61.19  (20.64) 60.10  (20.02)
Day 1: Cycle 3 Number Analyzed 109 participants 123 participants
-1.45  (21.03) -1.22  (22.42)
Day 1: Cycle 6 Number Analyzed 69 participants 102 participants
-0.12  (22.26) -0.16  (18.28)
Day 1: Cycle 9 Number Analyzed 55 participants 82 participants
1.06  (19.97) 0.41  (20.99)
Day 1: Cycle 17 Number Analyzed 10 participants 13 participants
-9.17  (24.36) -1.92  (19.29)
15.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score
Hide Description EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL
Time Frame Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
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Hide Analysis Population Description
Analysis was performed on safety population evaluable for disease symptoms. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 130 137
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 130 participants 135 participants
24.91  (20.67) 24.12  (20.54)
Day 1: Cycle 3 Number Analyzed 107 participants 121 participants
-3.79  (16.09) -2.07  (17.51)
Day 1: Cycle 6 Number Analyzed 68 participants 101 participants
-4.08  (17.95) -3.30  (16.01)
Day 1: Cycle 9 Number Analyzed 55 participants 81 participants
-2.83  (15.04) -4.66  (13.73)
Day 1: Cycle 17 Number Analyzed 10 participants 13 participants
-3.33  (15.54) 0.00  (21.40)
16.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score
Hide Description EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.
Time Frame Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
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Hide Analysis Population Description
Analysis was performed on safety population evaluable for side effects of treatment. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 130 137
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 130 participants 135 participants
17.49  (15.25) 15.60  (11.63)
Day 1: Cycle 3 Number Analyzed 107 participants 121 participants
1.69  (11.54) 2.61  (13.39)
Day 1: Cycle 6 Number Analyzed 68 participants 101 participants
-0.13  (15.10) 2.11  (11.78)
Day 1: Cycle 9 Number Analyzed 55 participants 81 participants
1.43  (14.66) 3.14  (11.88)
Day 1: Cycle 17 Number Analyzed 10 participants 13 participants
-2.93  (15.94) 3.02  (15.72)
17.Secondary Outcome
Title Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value
Hide Description The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
Time Frame Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population evaluable for health state utility index. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 134 140
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 134 participants 138 participants
0.70  (0.24) 0.71  (0.21)
Day 1: Cycle 3 Number Analyzed 109 participants 125 participants
-0.01  (0.22) -0.01  (0.22)
Day 1: Cycle 6 Number Analyzed 69 participants 101 participants
0.02  (0.22) -0.00  (0.20)
Day 1: Cycle 9 Number Analyzed 55 participants 82 participants
-0.03  (0.27) -0.01  (0.15)
Day 1: Cycle 17 Number Analyzed 10 participants 13 participants
-0.02  (0.19) -0.01  (0.23)
18.Secondary Outcome
Title Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)
Hide Description EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time Frame Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population evaluable for visual analogue scale. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 134 140
Mean (Standard Deviation)
Unit of Measure: centimeter
Baseline Number Analyzed 134 participants 138 participants
65.38  (19.31) 66.62  (19.32)
Day 1: Cycle 3 Number Analyzed 109 participants 125 participants
0.26  (17.37) 0.92  (19.41)
Day 1: Cycle 6 Number Analyzed 69 participants 101 participants
2.49  (18.83) 1.19  (17.70)
Day 1: Cycle 9 Number Analyzed 55 participants 82 participants
4.42  (19.78) 1.96  (16.60)
Day 1: Cycle 17 Number Analyzed 10 participants 13 participants
-1.70  (12.39) -3.00  (12.58)
19.Secondary Outcome
Title Percentage of Participants With Best Overall Response (BOR)
Hide Description BOR:best sequential response from start of treatment until disease progression,death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response(MR), stable disease(SD),PD, and not evaluable.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65),absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h. MR:>=25% but <=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.
Time Frame From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
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Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Measure Type: Number
Unit of Measure: percentage of participants
Stringent complete response 0.7 0
Complete response 1.3 4.5
Very good partial response 6.5 27.3
Partial response 26.8 28.6
Minimal response 11.1 6.5
Stable disease 29.4 21.4
Progressive Disease 9.2 3.9
Not evaluable 10.5 4.5
20.Secondary Outcome
Title Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit
Hide Description CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as >= 25% but <= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, >=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.
Time Frame From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Measure Type: Number
Unit of Measure: percentage of participants
46.4 66.9
21.Secondary Outcome
Title Percentage of Participants With Very Good Partial Response (VGPR)
Hide Description VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h or >=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response (CR), using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.
Time Frame From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Measure Type: Number
Unit of Measure: percentage of participants
8.5 31.8
22.Secondary Outcome
Title Time to First Response (TT1R)
Hide Description TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Time Frame From the date of randomization to the date of first IRC determined response, or death or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Median (95% Confidence Interval)
Unit of Measure: months
3.02
(2.825 to 5.060)
1.94
(1.314 to 2.004)
23.Secondary Outcome
Title Time to Best Response (TTBR)
Hide Description TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.
Time Frame From the date of randomization to date of first occurrence of IRC determined best overall response or data cut-off whichever comes first (maximum duration 76.7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 153 154
Median (95% Confidence Interval)
Unit of Measure: months
5.06
(3.778 to 7.885)
4.30
(2.891 to 5.125)
24.Secondary Outcome
Title Number of Participants With Minimal Residual Disease (MRD)
Hide Description MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.
Time Frame Up to 76.7 weeks
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Hide Analysis Population Description
Analysis was performed on ITT population who were evaluable for MRD.
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description:
Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).
Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
Overall Number of Participants Analyzed 2 14
Measure Type: Count of Participants
Unit of Measure: Participants
MRD negative:1 in 10^4
0
   0.0%
10
  71.4%
MRD negative:1 in 10^5
0
   0.0%
8
  57.1%
MRD negative:1 in 10^6
0
   0.0%
2
  14.3%
MRD positive:1 in 10^4
2
 100.0%
4
  28.6%
MRD positive:1 in 10^5
2
 100.0%
6
  42.9%
MRD positive:1 in 10^6
2
 100.0%
9
  64.3%
Time Frame AE data was collected from the time of signed informed consent to 30 days following the last administration of study treatment (up to 76.7 weeks).
Adverse Event Reporting Description Reported AEs and deaths are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). Analysis was performed on safety population.
 
Arm/Group Title Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Hide Arm/Group Description Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks). Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
All-Cause Mortality
Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Affected / at Risk (%) Affected / at Risk (%)
Total   13/149 (8.72%)      11/152 (7.24%)    
Hide Serious Adverse Events
Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/149 (53.69%)      94/152 (61.84%)    
Blood and lymphatic system disorders     
Anaemia  1  1/149 (0.67%)  1 3/152 (1.97%)  4
Febrile Neutropenia  1  3/149 (2.01%)  3 10/152 (6.58%)  11
Hyperviscosity Syndrome  1  2/149 (1.34%)  2 0/152 (0.00%)  0
Neutropenia  1  2/149 (1.34%)  2 5/152 (3.29%)  5
Pancytopenia  1  1/149 (0.67%)  1 1/152 (0.66%)  1
Thrombocytopenia  1  1/149 (0.67%)  1 3/152 (1.97%)  3
Cardiac disorders     
Acute Coronary Syndrome  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Angina Pectoris  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Angina Unstable  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Arrhythmia Supraventricular  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Atrial Fibrillation  1  1/149 (0.67%)  1 3/152 (1.97%)  4
Cardiac Failure  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Eye disorders     
Retinal Detachment  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Gastrointestinal disorders     
Colitis Ischaemic  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Diarrhoea  1  1/149 (0.67%)  1 1/152 (0.66%)  1
Diverticular Perforation  1  0/149 (0.00%)  0 2/152 (1.32%)  3
Oesophagitis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pancreatitis Acute  1  1/149 (0.67%)  1 0/152 (0.00%)  0
General disorders     
Asthenia  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Death  1  1/149 (0.67%)  1 2/152 (1.32%)  2
Disease Progression  1  7/149 (4.70%)  7 7/152 (4.61%)  7
General Physical Health Deterioration  1  2/149 (1.34%)  2 1/152 (0.66%)  1
Multiple Organ Dysfunction Syndrome  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Peripheral Swelling  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pyrexia  1  2/149 (1.34%)  2 3/152 (1.97%)  3
Sudden Death  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Hepatic Failure  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Infections and infestations     
Acarodermatitis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Atypical Pneumonia  1  0/149 (0.00%)  0 2/152 (1.32%)  2
Bronchiolitis  1  0/149 (0.00%)  0 2/152 (1.32%)  2
Bronchitis  1  1/149 (0.67%)  1 3/152 (1.97%)  3
Candida Pneumonia  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Cytomegalovirus Gastrointestinal Infection  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Device Related Sepsis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Diverticulitis  1  1/149 (0.67%)  1 2/152 (1.32%)  2
Escherichia Sepsis  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Gastroenteritis  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Gastroenteritis Enteroviral  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Haemophilus Infection  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Herpes Zoster Disseminated  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Infection  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Influenza  1  2/149 (1.34%)  2 3/152 (1.97%)  3
Laryngitis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Lower Respiratory Tract Infection  1  3/149 (2.01%)  3 4/152 (2.63%)  4
Lung Infection  1  3/149 (2.01%)  3 3/152 (1.97%)  3
Lymphangitis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Medical Device Site Infection  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Orchitis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pneumocystis Jirovecii Pneumonia  1  4/149 (2.68%)  4 3/152 (1.97%)  3
Pneumonia  1  23/149 (15.44%)  23 23/152 (15.13%)  27
Pneumonia Bacterial  1  0/149 (0.00%)  0 2/152 (1.32%)  3
Pneumonia Fungal  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pneumonia Haemophilus  1  0/149 (0.00%)  0 2/152 (1.32%)  2
Pneumonia Influenzal  1  2/149 (1.34%)  2 2/152 (1.32%)  2
Pneumonia Pneumococcal  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pneumonia Streptococcal  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Pneumonia Viral  1  0/149 (0.00%)  0 3/152 (1.97%)  3
Postoperative Wound Infection  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pseudomonal Bacteraemia  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pseudomonas Infection  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pyelonephritis  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Pyelonephritis Acute  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Respiratory Tract Infection  1  2/149 (1.34%)  2 2/152 (1.32%)  2
Respiratory Tract Infection Viral  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Sepsis  1  2/149 (1.34%)  2 4/152 (2.63%)  4
Septic Shock  1  3/149 (2.01%)  3 1/152 (0.66%)  1
Sinusitis  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Skin Infection  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Soft Tissue Infection  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Staphylococcal Bacteraemia  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Upper Respiratory Tract Infection  1  2/149 (1.34%)  2 2/152 (1.32%)  2
Urinary Tract Infection  1  2/149 (1.34%)  2 6/152 (3.95%)  6
Varicella  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Injury, poisoning and procedural complications     
Accidental Overdose  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Fall  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Head Injury  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Infusion Related Reaction  1  1/149 (0.67%)  1 6/152 (3.95%)  6
Traumatic Fracture  1  0/149 (0.00%)  0 3/152 (1.97%)  3
Wound Complication  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Investigations     
Alanine Aminotransferase Increased  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Hepatic Enzyme Increased  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Metabolism and nutrition disorders     
Decreased Appetite  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Dehydration  1  1/149 (0.67%)  1 1/152 (0.66%)  1
Hypercalcaemia  1  3/149 (2.01%)  4 2/152 (1.32%)  2
Hyperglycaemia  1  0/149 (0.00%)  0 3/152 (1.97%)  4
Hyponatraemia  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Malnutrition  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Tumour Lysis Syndrome  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/149 (1.34%)  2 4/152 (2.63%)  4
Back Pain  1  1/149 (0.67%)  1 2/152 (1.32%)  2
Bone Pain  1  0/149 (0.00%)  0 2/152 (1.32%)  2
Muscular Weakness  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Osteoporotic Fracture  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pathological Fracture  1  3/149 (2.01%)  3 5/152 (3.29%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Myelodysplastic Syndrome  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Squamous Cell Carcinoma Of Skin  1  0/149 (0.00%)  0 3/152 (1.97%)  4
Tumour Associated Fever  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Nervous system disorders     
Ataxia  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Cauda Equina Syndrome  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Cerebral Haemorrhage  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Haemorrhage Intracranial  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Intracranial Aneurysm  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Ischaemic Stroke  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Presyncope  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Spinal Subdural Haematoma  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Syncope  1  1/149 (0.67%)  1 4/152 (2.63%)  4
Transient Ischaemic Attack  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Vith Nerve Paresis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Vocal Cord Paralysis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Psychiatric disorders     
Acute Psychosis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Confusional State  1  1/149 (0.67%)  1 1/152 (0.66%)  1
Renal and urinary disorders     
Acute Kidney Injury  1  6/149 (4.03%)  8 5/152 (3.29%)  5
Hydronephrosis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Renal Aneurysm  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Renal Failure  1  3/149 (2.01%)  4 1/152 (0.66%)  1
Renal Impairment  1  0/149 (0.00%)  0 2/152 (1.32%)  2
Reproductive system and breast disorders     
Pelvic Pain  1  0/149 (0.00%)  0 2/152 (1.32%)  2
Respiratory, thoracic and mediastinal disorders     
Bronchopneumopathy  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Chronic Obstructive Pulmonary Disease  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Cough  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Dyspnoea  1  2/149 (1.34%)  2 4/152 (2.63%)  4
Haemothorax  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Hiccups  1  0/149 (0.00%)  0 1/152 (0.66%)  2
Hypoxia  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Pleural Effusion  1  1/149 (0.67%)  1 1/152 (0.66%)  1
Pulmonary Embolism  1  2/149 (1.34%)  2 3/152 (1.97%)  3
Pulmonary Oedema  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Respiratory Failure  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus Ulcer  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Vascular disorders     
Arteriosclerosis  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Deep Vein Thrombosis  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Hypertension  1  1/149 (0.67%)  1 0/152 (0.00%)  0
Hypotension  1  0/149 (0.00%)  0 1/152 (0.66%)  1
Orthostatic Hypotension  1  1/149 (0.67%)  1 0/152 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pd (Pomalidomide + Dexamethasone) IPd (Isatuximab + Pomalidomide + Dexamethasone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   137/149 (91.95%)      142/152 (93.42%)    
Blood and lymphatic system disorders     
Febrile Neutropenia  1  0/149 (0.00%)  0 8/152 (5.26%)  10
Neutropenia  1  48/149 (32.21%)  76 69/152 (45.39%)  118
Thrombocytopenia  1  17/149 (11.41%)  18 16/152 (10.53%)  24
Gastrointestinal disorders     
Constipation  1  26/149 (17.45%)  31 24/152 (15.79%)  27
Diarrhoea  1  28/149 (18.79%)  37 38/152 (25.00%)  58
Nausea  1  14/149 (9.40%)  14 23/152 (15.13%)  26
Stomatitis  1  4/149 (2.68%)  4 10/152 (6.58%)  11
Vomiting  1  5/149 (3.36%)  5 18/152 (11.84%)  20
General disorders     
Asthenia  1  27/149 (18.12%)  32 22/152 (14.47%)  29
Fatigue  1  32/149 (21.48%)  33 26/152 (17.11%)  31
Oedema Peripheral  1  16/149 (10.74%)  19 20/152 (13.16%)  23
Pyrexia  1  19/149 (12.75%)  21 19/152 (12.50%)  21
Infections and infestations     
Bronchitis  1  12/149 (8.05%)  13 34/152 (22.37%)  51
Nasopharyngitis  1  7/149 (4.70%)  9 14/152 (9.21%)  19
Pneumonia  1  5/149 (3.36%)  5 14/152 (9.21%)  14
Upper Respiratory Tract Infection  1  25/149 (16.78%)  33 41/152 (26.97%)  66
Urinary Tract Infection  1  13/149 (8.72%)  15 11/152 (7.24%)  12
Injury, poisoning and procedural complications     
Fall  1  8/149 (5.37%)  10 7/152 (4.61%)  7
Infusion Related Reaction  1  1/149 (0.67%)  1 51/152 (33.55%)  55
Investigations     
Weight Decreased  1  2/149 (1.34%)  3 10/152 (6.58%)  10
Metabolism and nutrition disorders     
Decreased Appetite  1  7/149 (4.70%)  7 14/152 (9.21%)  18
Musculoskeletal and connective tissue disorders     
Arthralgia  1  11/149 (7.38%)  11 13/152 (8.55%)  14
Back Pain  1  21/149 (14.09%)  22 24/152 (15.79%)  26
Bone Pain  1  8/149 (5.37%)  9 10/152 (6.58%)  10
Muscle Spasms  1  15/149 (10.07%)  17 14/152 (9.21%)  14
Muscular Weakness  1  7/149 (4.70%)  7 10/152 (6.58%)  10
Musculoskeletal Chest Pain  1  7/149 (4.70%)  7 13/152 (8.55%)  13
Myalgia  1  5/149 (3.36%)  5 10/152 (6.58%)  11
Nervous system disorders     
Dizziness  1  4/149 (2.68%)  4 8/152 (5.26%)  9
Headache  1  8/149 (5.37%)  8 15/152 (9.87%)  16
Peripheral Sensory Neuropathy  1  9/149 (6.04%)  9 11/152 (7.24%)  12
Tremor  1  6/149 (4.03%)  6 12/152 (7.89%)  13
Psychiatric disorders     
Insomnia  1  12/149 (8.05%)  14 13/152 (8.55%)  14
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/149 (6.71%)  13 14/152 (9.21%)  20
Dyspnoea  1  13/149 (8.72%)  14 21/152 (13.82%)  24
Oropharyngeal Pain  1  3/149 (2.01%)  3 8/152 (5.26%)  11
Skin and subcutaneous tissue disorders     
Pruritus  1  9/149 (6.04%)  10 5/152 (3.29%)  5
Rash  1  8/149 (5.37%)  8 5/152 (3.29%)  6
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02990338    
Other Study ID Numbers: EFC14335
2016-003097-41 ( EudraCT Number )
U1111-1180-6262 ( Other Identifier: UTN )
First Submitted: December 4, 2016
First Posted: December 13, 2016
Results First Submitted: November 19, 2019
Results First Posted: December 6, 2019
Last Update Posted: February 24, 2021