Trial Outcomes & Findings for Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma (NCT NCT05288062)
NCT ID: NCT05288062
Last Updated: 2025-08-20
Results Overview
RR is defined as a binary variable. A success will be defined as patient who achieve a response of a partial response (PR) or better using the International Myeloma Working Group (IMWG) criteria. Biomarkers of interest will be identified and categorized into clinically relevant groups (e.g. positive vs. negative) by evaluating baseline and post treatment (after cycle one) biospecimens. RR will be estimated within each biomarker. Each cohort (A-D) will be evaluated separately and independently.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
21 days
Results posted on
2025-08-20
Participant Flow
Participant milestones
| Measure |
Cohort A (Lenalidomide, Dexamethasone)
Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort B (Lenalidomide, Dexamethasone)
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
5
|
12
|
0
|
|
Overall Study
COMPLETED
|
0
|
5
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A (Lenalidomide, Dexamethasone)
Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort B (Lenalidomide, Dexamethasone)
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
|---|---|---|---|---|
|
Overall Study
Ineligible
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort A (Lenalidomide, Dexamethasone)
Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort B (Lenalidomide, Dexamethasone)
n=5 Participants
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
n=10 Participants
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
61.4 years
STANDARD_DEVIATION 15.2 • n=107 Participants
|
69.9 years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
—
|
67.1 years
STANDARD_DEVIATION 13.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
—
|
13 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
—
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
—
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
—
|
15 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Only patients that completed the study were included in analysis
RR is defined as a binary variable. A success will be defined as patient who achieve a response of a partial response (PR) or better using the International Myeloma Working Group (IMWG) criteria. Biomarkers of interest will be identified and categorized into clinically relevant groups (e.g. positive vs. negative) by evaluating baseline and post treatment (after cycle one) biospecimens. RR will be estimated within each biomarker. Each cohort (A-D) will be evaluated separately and independently.
Outcome measures
| Measure |
Cohort A (Lenalidomide, Dexamethasone)
Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort B (Lenalidomide, Dexamethasone)
n=5 Participants
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
|
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
n=10 Participants
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy
Dexamethasone: Given orally
Lenalidomide: Given orally
Pomalidomide: Given orally
|
|---|---|---|---|---|
|
Response Rates (RR) at First Assessment
|
—
|
1 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsBiomarkers and RR will be analyzed using logistic regressions to identify predictive biomarkers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to completion of 1 cycle of treatment (21 days)Chi-square (or Fischer Exact) test and 95% confidence intervals will be estimated to compared AA and white patients descriptively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsCorrelation between the depth of hematological responses and biomarkers will be estimated. Logistic regressions and chi square (or Fischer exact) testing will be utilized.
Outcome measures
Outcome data not reported
Adverse Events
Cohort B (Lenalidomide, Dexamethasone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort B (Lenalidomide, Dexamethasone)
n=5 participants at risk
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
|
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
n=11 participants at risk
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Cohort B (Lenalidomide, Dexamethasone)
n=5 participants at risk
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
|
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
n=11 participants at risk
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 2 • 1 year
|
18.2%
2/11 • Number of events 2 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/11 • 1 year
|
|
Eye disorders
Eye pain
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/11 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • 1 year
|
18.2%
2/11 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/11 • 1 year
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 3 • 1 year
|
36.4%
4/11 • Number of events 4 • 1 year
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Immune system disorders
Allergic reaction
|
20.0%
1/5 • Number of events 1 • 1 year
|
9.1%
1/11 • Number of events 2 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/11 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Investigations
INR increased
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 1 • 1 year
|
27.3%
3/11 • Number of events 4 • 1 year
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • 1 year
|
36.4%
4/11 • Number of events 7 • 1 year
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • Number of events 2 • 1 year
|
18.2%
2/11 • Number of events 5 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
40.0%
2/5 • Number of events 2 • 1 year
|
0.00%
0/11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • 1 year
|
18.2%
2/11 • Number of events 2 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 1 year
|
9.1%
1/11 • Number of events 2 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • 1 year
|
9.1%
1/11 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place