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Trial record 10 of 794 for:    LENALIDOMIDE AND cells

Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT02880228
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : July 17, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plasma Cell Myeloma
Interventions Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Biological: Pembrolizumab
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
All patients that began protocol treatment are included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
59
(42 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
  90.9%
Unknown or Not Reported
1
   9.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
  90.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Proportion of Complete Response Plus Very Good Partial Response (VGPR)
Hide Description

The International Myeloma Working Group response criteria was used to assess response to therapy. The proportion of VGPR response at any time during treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients achieving a VGPR, CR, or sCR at any time divided by the total number of evaluable patients. A very good partial response (VGPR) is defined as as a demonstration of:

  • Serum and urine M-component detectable by immunofixation but not on electrophoresis c or
  • greater than 90% reduction in serum m-component and urine m-component <100 mg/24 h
  • If the only measurable disease is FLC, a ≥90% reduction in the difference between involved and involved FLC levels

The proportion of successes will be estimated by the number of patients demonstrating a VGPR or better divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Time Frame Up to 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description:
Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Overall Number of Participants Analyzed 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0
(0 to 0.28)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Time Frame From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment were included in this analysis.
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description:
Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Too few events occurred to estimate the median and confidence interval.
3.Secondary Outcome
Title Partial Response (PR)
Hide Description

The PR response after 4 cycles of induction treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients who achieve a PR, VGPR, CR, or sCR after 4 cycles divided by the total number of evaluable patients. A PR is defined by the following criteria: >

  • If present at baseline, ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to <200 mg/24hrs >
  • If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and involved FLC levels >
  • If the only measurable disease is BM, a ≥50% reduction in BM PC's (provided the baseline PC's was ≥30%) >
  • If present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas >

Exact binomial 95% confidence intervals for the true success rate will be calculated.

Time Frame Up to 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients that completed 4 cycles of treatment were included in this endpoint.
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description:
Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0
(0 to 0.52)
4.Secondary Outcome
Title Proportion of Successful Stem Cell Collection
Hide Description The proportion of successful stem cell collection following initial therapy with the combination of pembrolizumab, lenalidomide and dexamethasone in patients with newly diagnosed MM will be estimated by the number of patients with a successful stem cell collection divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true successful proportion will be calculated.
Time Frame Up to 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients that completed 4 cycles of treatment were eligible for this endpoint.
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description:
Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Overall Number of Participants Analyzed 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.4
(0.05 to 0.85)
5.Secondary Outcome
Title Survival Time
Hide Description Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame From time of registration to death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment are included in this analysis.
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description:
Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Too few events occurred to estimate a median and confidence interval.
Time Frame Adverse events were collected after every 28 day cycles during treatment, up to 7 cycles.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Hide Arm/Group Description Patients receive 25 mg lenalidomide PO daily on days 1-21 and 40 mg dexamethasone PO daily on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive 200 mg pembrolizumab IV over 30 minutes on days 1 and 22 of course 1, day 15 of course 2, and day 8 of course 3. Courses 1-3 repeat beyond 3 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo stem cell transplantation after 4 courses of treatment.
All-Cause Mortality
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Affected / at Risk (%)
Total   0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Affected / at Risk (%) # Events
Total   3/11 (27.27%)    
Blood and lymphatic system disorders   
Anemia  1  1/11 (9.09%)  1
Cardiac disorders   
Heart failure  1  1/11 (9.09%)  1
General disorders   
Edema limbs  1  1/11 (9.09%)  1
Fever  1  1/11 (9.09%)  1
Infections and infestations   
Infections and infestations - Other, specify  1  1/11 (9.09%)  1
Sepsis  1  1/11 (9.09%)  1
Investigations   
Neutrophil count decreased  1  1/11 (9.09%)  1
Platelet count decreased  1  2/11 (18.18%)  2
White blood cell decreased  1  1/11 (9.09%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/11 (9.09%)  1
Hypocalcemia  1  1/11 (9.09%)  1
Nervous system disorders   
Seizure  1  1/11 (9.09%)  1
Reproductive system and breast disorders   
Reproductive system and breast disorders - Other, specify  1  1/11 (9.09%)  1
Vascular disorders   
Hypertension  1  1/11 (9.09%)  1
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Lenalidomide, Dexamethasone, Pembrolizumab)
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  9/11 (81.82%)  25
Gastrointestinal disorders   
Constipation  1  4/11 (36.36%)  13
Diarrhea  1  3/11 (27.27%)  5
Nausea  1  2/11 (18.18%)  2
Vomiting  1  1/11 (9.09%)  1
General disorders   
Fatigue  1  9/11 (81.82%)  27
Investigations   
Creatinine increased  1  2/11 (18.18%)  2
Hemoglobin increased  1  1/11 (9.09%)  1
Neutrophil count decreased  1  4/11 (36.36%)  5
Platelet count decreased  1  5/11 (45.45%)  9
White blood cell decreased  1  5/11 (45.45%)  6
Metabolism and nutrition disorders   
Hypokalemia  1  1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  3/11 (27.27%)  4
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shaji K Kumar MD
Organization: Mayo Clinic
Phone: 5072842511
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02880228     History of Changes
Other Study ID Numbers: MC1588
NCI-2016-01290 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1588 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: August 18, 2016
First Posted: August 26, 2016
Results First Submitted: June 25, 2019
Results First Posted: July 17, 2019
Last Update Posted: July 30, 2019