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Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01615029
Recruitment Status : Active, not recruiting
First Posted : June 8, 2012
Results First Posted : April 14, 2017
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Part 1 (Dose Escalation): Daratumumab
Drug: Part 2 (Dose Expansion): Daratumumab
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Period Title: Overall Study
Started 3 3 4 3 32
Completed 0 0 0 0 0
Not Completed 3 3 4 3 32
Reason Not Completed
Adverse Event             0             0             0             0             1
Death             0             0             0             0             1
Lost to Follow-up             0             0             0             0             1
Progressive disease             2             1             1             1             5
Physician Decision             0             0             0             0             1
Ongoing             1             2             3             2             23
Arm/Group Title Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Total
Hide Arm/Group Description Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Total of all reporting groups
Overall Number of Baseline Participants 3 3 4 3 32 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 4 participants 3 participants 32 participants 45 participants
62.7  (12.74) 62.7  (2.08) 57.5  (9.68) 67.3  (10.26) 59.7  (8.38) 60.4  (8.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 32 participants 45 participants
Female
0
   0.0%
1
  33.3%
0
   0.0%
2
  66.7%
10
  31.3%
13
  28.9%
Male
3
 100.0%
2
  66.7%
4
 100.0%
1
  33.3%
22
  68.8%
32
  71.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 32 participants 45 participants
Denmark 2 2 1 1 5 11
France 0 0 0 1 6 7
Italy 0 0 0 0 8 8
Netherlands 0 0 3 0 6 9
United Kingdom 1 1 0 1 4 7
United States 0 0 0 0 3 3
Stage of Disease [International Staging System (ISS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 32 participants 45 participants
I 0 1 4 1 15 21
II 2 1 0 1 14 18
III 1 1 0 1 3 6
[1]
Measure Description: The International Staging System (ISS) system consists of stage I: beta2 microglobulin less than (<)3.5 milligram per liter (mg/L) and albumin greater than or equal to (>=) 3.5 gram/ deciliter (dL) or (35 gram/L); stage II: neither stage I nor stage III and stage III: beta2 microglobulin >= 5.5 mg/L.
No. of Prior Lines of Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 32 participants 45 participants
1 Line 0 0 0 0 15 15
2-3 Lines 2 3 3 2 17 27
>3 Lines 1 0 1 1 0 3
Refractory to Proteasome Inhibitor (PI)/Immunomodulatory drug (IMiD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 3 participants 32 participants 45 participants
Both a PI and IMiD 0 0 3 1 0 4
PI only 0 2 0 0 5 7
IMiD only 0 1 0 1 1 3
None 3 0 1 1 26 31
1.Primary Outcome
Title Phase 1: Percentage of Participants With Overall Response Rate (ORR)
Hide Description ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.
Arm/Group Title Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 3 3 4 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(29.2 to 100.0)
100.0
(29.2 to 100.0)
75.0
(19.4 to 99.4)
66.7
(9.4 to 99.2)
2.Primary Outcome
Title Phase 2: Percentage of Participants With Overall Response Rate (ORR)
Hide Description ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Arm/Group Title Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
81.3
(63.6 to 92.8)
3.Secondary Outcome
Title Phase 2: Time to Progression (TTP)
Hide Description TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of >=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Arm/Group Title Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Median and Confidence Interval was not estimable due to insufficient number of participants with events.
4.Secondary Outcome
Title Phase 2: Duration of Response
Hide Description Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Responders in Intent-to-Treat (ITT) population analysis set included.
Arm/Group Title Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Median and CI was not estimable due to insufficient number of participants with events.
5.Secondary Outcome
Title Phase 2: Progression-Free Survival (PFS)
Hide Description Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Arm/Group Title Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Median and confidence interval (CI) was not estimable due to insufficient number of participants with events.
6.Secondary Outcome
Title Phase 1: Time to Response
Hide Description Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Responders in all treated population analysis set included.
Arm/Group Title Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 3 3 3 2
Mean (Standard Deviation)
Unit of Measure: Months
Time to first response 0.83  (0.266) 1.14  (0.682) 1.27  (0.494) 2.25  (0.488)
Time to best response 3.12  (2.938) 12.54  (8.494) 9.75  (9.532) 5.47  (1.464)
7.Secondary Outcome
Title Phase 2: Time to Response
Hide Description Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Arm/Group Title Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Months
Time to first response 1.55  (1.363)
Time to best response 5.60  (3.817)
8.Secondary Outcome
Title Phase 2: Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Arm/Group Title Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description:
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
Median and CI was not estimable due to insufficient number of participants with events.
Time Frame Screening to End of the study (Up to 3 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Hide Arm/Group Description Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days. Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
All-Cause Mortality
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/3 (66.67%)   2/4 (50.00%)   2/3 (66.67%)   16/32 (50.00%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Neutropenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Cardiac disorders           
Atrial Fibrillation * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Endocrine disorders           
Steroid Withdrawal Syndrome * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Eye disorders           
Retinal Artery Thrombosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Vitreous Detachment * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Diarrhoea * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
General disorders           
Pyrexia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Infections and infestations           
Bronchitis * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Gastroenteritis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Lower Respiratory Tract Infection * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Nasopharyngitis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Pneumonia * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Pneumonia Viral * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Upper Respiratory Tract Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Urinary Tract Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Viral Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Injury, poisoning and procedural complications           
Pelvic Fracture * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Spinal Fracture * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Investigations           
Influenza A Virus Test Positive * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders           
Back Pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Osteonecrosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Adenocarcinoma Gastric * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Nervous system disorders           
Cerebral Infarction * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Cerebrovascular Accident * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Syncope * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Laryngeal Oedema * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Pulmonary Embolism * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   4/4 (100.00%)   3/3 (100.00%)   31/32 (96.88%) 
Blood and lymphatic system disorders           
Anaemia * 1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%)  1/3 (33.33%)  8/32 (25.00%) 
Leukocytosis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Leukopenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  7/32 (21.88%) 
Lymphopenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  4/32 (12.50%) 
Neutropenia * 1  3/3 (100.00%)  1/3 (33.33%)  4/4 (100.00%)  2/3 (66.67%)  27/32 (84.38%) 
Thrombocytopenia * 1  1/3 (33.33%)  2/3 (66.67%)  2/4 (50.00%)  0/3 (0.00%)  10/32 (31.25%) 
Cardiac disorders           
Atrial Fibrillation * 1  2/3 (66.67%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Bradycardia * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Palpitations * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Supraventricular Tachycardia * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Ear and labyrinth disorders           
Tinnitus * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Vertigo * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Endocrine disorders           
Pituitary-Dependent Cushing's Syndrome * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Steroid Withdrawal Syndrome * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Eye disorders           
Cataract * 1  0/3 (0.00%)  3/3 (100.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Glaucoma * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Lacrimation Increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Retinal Artery Thrombosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Vision Blurred * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Gastrointestinal disorders           
Abdominal Discomfort * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Abdominal Pain * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Abdominal Pain Upper * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Constipation * 1  3/3 (100.00%)  3/3 (100.00%)  1/4 (25.00%)  1/3 (33.33%)  6/32 (18.75%) 
Diarrhoea * 1  2/3 (66.67%)  3/3 (100.00%)  3/4 (75.00%)  1/3 (33.33%)  14/32 (43.75%) 
Dyspepsia * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Faeces Discoloured * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Gastrooesophageal Reflux Disease * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Haemorrhoids * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Hypoaesthesia Oral * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Mouth Ulceration * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Nausea * 1  1/3 (33.33%)  2/3 (66.67%)  2/4 (50.00%)  0/3 (0.00%)  9/32 (28.13%) 
Tongue Blistering * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Toothache * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Vomiting * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  4/32 (12.50%) 
General disorders           
Application Site Erythema * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Asthenia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  4/32 (12.50%) 
Chest Pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Facial Pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Fatigue * 1  3/3 (100.00%)  0/3 (0.00%)  4/4 (100.00%)  1/3 (33.33%)  11/32 (34.38%) 
Inflammation * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Influenza Like Illness * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Oedema * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  1/3 (33.33%)  2/32 (6.25%) 
Oedema Peripheral * 1  2/3 (66.67%)  0/3 (0.00%)  1/4 (25.00%)  3/3 (100.00%)  8/32 (25.00%) 
Pain * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Peripheral Swelling * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Pyrexia * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  8/32 (25.00%) 
Immune system disorders           
Hypogammaglobulinaemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Immune System Disorder * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Infections and infestations           
Bronchitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  2/3 (66.67%)  6/32 (18.75%) 
Cellulitis * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Conjunctivitis * 1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Cystitis * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Diarrhoea Infectious * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Fungal Skin Infection * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Gastroenteritis * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  2/32 (6.25%) 
Herpes Zoster * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Influenza * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Lower Respiratory Tract Infection * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Lower Respiratory Tract Infection Viral * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Lung Infection * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Nasopharyngitis * 1  1/3 (33.33%)  2/3 (66.67%)  3/4 (75.00%)  2/3 (66.67%)  6/32 (18.75%) 
Oral Candidiasis * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Oral Herpes * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Oral Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Pharyngitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  4/32 (12.50%) 
Pneumonia * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/3 (0.00%)  0/32 (0.00%) 
Postoperative Wound Infection * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Respiratory Tract Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Rhinitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  5/32 (15.63%) 
Sinusitis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Tooth Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Upper Respiratory Tract Infection * 1  1/3 (33.33%)  2/3 (66.67%)  2/4 (50.00%)  0/3 (0.00%)  7/32 (21.88%) 
Urinary Tract Infection * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Viral Infection * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Viral Upper Respiratory Tract Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Vulvovaginal Mycotic Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Injury, poisoning and procedural complications           
Clavicle Fracture * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Contusion * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Limb Injury * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Pelvic Fracture * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Investigations           
Alanine Aminotransferase Increased * 1  2/3 (66.67%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Aspartate Aminotransferase Increased * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Blood Alkaline Phosphatase Increased * 1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Blood Creatine Phosphokinase Increased * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Blood Lactate Dehydrogenase Increased * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Blood Phosphorus Decreased * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Blood Pressure Increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
C-Reactive Protein Increased * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Creatinine Renal Clearance Decreased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Electrocardiogram QT Prolonged * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  0/32 (0.00%) 
Weight Decreased * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Metabolism and nutrition disorders           
Decreased Appetite * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Hyperglycaemia * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  1/32 (3.13%) 
Hyperuricaemia * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Hypocalcaemia * 1  1/3 (33.33%)  2/3 (66.67%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Hypokalaemia * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  2/32 (6.25%) 
Hypomagnesaemia * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Hypophosphataemia * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  1/32 (3.13%) 
Arthritis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Back Pain * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  6/32 (18.75%) 
Bone Pain * 1  1/3 (33.33%)  1/3 (33.33%)  2/4 (50.00%)  0/3 (0.00%)  6/32 (18.75%) 
Gouty Arthritis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Joint Contracture * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Muscle Spasms * 1  1/3 (33.33%)  3/3 (100.00%)  3/4 (75.00%)  3/3 (100.00%)  14/32 (43.75%) 
Muscular Weakness * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Musculoskeletal Chest Pain * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Musculoskeletal Pain * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  2/32 (6.25%) 
Myalgia * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/3 (0.00%)  3/32 (9.38%) 
Myopathy * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Osteonecrosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Osteonecrosis of Jaw * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Pain in Extremity * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  4/32 (12.50%) 
Pain in Jaw * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Tendonitis * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Nervous system disorders           
Dizziness * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  2/32 (6.25%) 
Dizziness Postural * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Dysgeusia * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Headache * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  1/3 (33.33%)  5/32 (15.63%) 
Paraesthesia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  2/32 (6.25%) 
Peripheral Sensory Neuropathy * 1  1/3 (33.33%)  1/3 (33.33%)  2/4 (50.00%)  1/3 (33.33%)  7/32 (21.88%) 
Post Herpetic Neuralgia * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Sciatica * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Tremor * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  2/32 (6.25%) 
Visual Field Defect * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Psychiatric disorders           
Agitation * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Depressed Mood * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Depression * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Disinhibition * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Insomnia * 1  1/3 (33.33%)  2/3 (66.67%)  3/4 (75.00%)  0/3 (0.00%)  5/32 (15.63%) 
Mood Altered * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Renal and urinary disorders           
Dysuria * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Nocturia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Pollakiuria * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Polyuria * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Renal Impairment * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Urinary Retention * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Allergic Bronchitis * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Bronchospasm * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1/32 (3.13%) 
Cough * 1  0/3 (0.00%)  1/3 (33.33%)  2/4 (50.00%)  1/3 (33.33%)  16/32 (50.00%) 
Dry Throat * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Dysphonia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Dyspnoea * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  1/3 (33.33%)  3/32 (9.38%) 
Dyspnoea Exertional * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Epistaxis * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Nasal Congestion * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/3 (0.00%)  2/32 (6.25%) 
Oropharyngeal Pain * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Productive Cough * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Rhinitis Allergic * 1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%)  1/3 (33.33%)  4/32 (12.50%) 
Wheezing * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermal Cyst * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Ecchymosis * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Eczema * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Hyperhidrosis * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  1/3 (33.33%)  3/32 (9.38%) 
Pruritus * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  1/32 (3.13%) 
Purpura * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  0/32 (0.00%) 
Rash * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
Rash Generalised * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Skin Disorder * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  0/32 (0.00%) 
Skin Fragility * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Skin Lesion * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  1/32 (3.13%) 
Skin Ulcer * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  0/32 (0.00%) 
Vascular disorders           
Flushing * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  2/32 (6.25%) 
Hypertension * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/3 (0.00%)  9/32 (28.13%) 
Hypotension * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/3 (0.00%)  3/32 (9.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Research
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01615029     History of Changes
Other Study ID Numbers: CR101391
GEN503 ( Other Identifier: Genmab )
DARA-GEN503 ( Other Identifier: Janssen Research & Development, LLC )
2011-005709-62 ( EudraCT Number )
First Submitted: June 6, 2012
First Posted: June 8, 2012
Results First Submitted: February 2, 2017
Results First Posted: April 14, 2017
Last Update Posted: November 8, 2019