Trial Outcomes & Findings for Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide (NCT NCT01794039)
NCT ID: NCT01794039
Last Updated: 2018-08-21
Results Overview
The proportion of successes will be estimated in each arm independently by the number of successes 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. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
COMPLETED
PHASE2
9 participants
Up to 2 years
2018-08-21
Participant Flow
Participant milestones
| Measure |
Arm A (Lenalidomide, Dexamethasone)
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.\> \> Dexamethasone: Given PO\>
\> Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Dexamethasone: Given PO\>
\> Pomalidomide: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide
Baseline characteristics by cohort
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=5 Participants
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.\> \> Dexamethasone: Given PO\>
\> Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
n=4 Participants
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Dexamethasone: Given PO\>
\> Pomalidomide: Given PO
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
68.5 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All patients that received treatment were evaluable for response
The proportion of successes will be estimated in each arm independently by the number of successes 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. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Outcome measures
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=5 Participants
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.
\>
\> Dexamethasone: Given PO
\>
\> Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
n=4 Participants
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Dexamethasone: Given PO
\>
\> Pomalidomide: Given PO
|
|---|---|---|
|
Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
|
.4 proportion of participants
Interval 0.05 to 0.85
|
.25 proportion of participants
Interval 0.006 to 0.81
|
SECONDARY outcome
Timeframe: Up to 30 days after last day of study drug treatmentPopulation: All treated patients are evaluable for Adverse Events
Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.
Outcome measures
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=5 Participants
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.
\>
\> Dexamethasone: Given PO
\>
\> Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
n=4 Participants
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Dexamethasone: Given PO
\>
\> Pomalidomide: Given PO
|
|---|---|---|
|
Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 2 yearsPopulation: All patients that received Arm A or Arm B treatment.
The distribution of survival time will be estimated using the method of Kaplan-Meier. Due to an early closer from slow accrual the data from both arms was combined in survival analysis.
Outcome measures
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=9 Participants
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.
\>
\> Dexamethasone: Given PO
\>
\> Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Dexamethasone: Given PO
\>
\> Pomalidomide: Given PO
|
|---|---|---|
|
Overall Survival
|
13.4 Months
Interval 9.3 to
Upper confidence interval was not reached
|
—
|
SECONDARY outcome
Timeframe: Time from registration to the earliest date with documentation of disease progression, assessed up to 2 yearsPopulation: All patients that received Arm A or Arm B treatment.
The distribution of time to progression will be estimated using the method of Kaplan-Meier. The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Outcome measures
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=9 Participants
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.
\>
\> Dexamethasone: Given PO
\>
\> Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> Dexamethasone: Given PO
\>
\> Pomalidomide: Given PO
|
|---|---|---|
|
Time to Progression
|
10 Months
Interval 4.1 to 12.4
|
—
|
Adverse Events
Arm A (Lenalidomide, Dexamethasone)
Arm B (Pomalidomide, Dexamethasone)
Serious adverse events
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=5 participants at risk
Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
n=4 participants at risk
Pomalidomide: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Lung infection
|
40.0%
2/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/5
|
25.0%
1/4 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Arm A (Lenalidomide, Dexamethasone)
n=5 participants at risk
Lenalidomide: Given PO
|
Arm B (Pomalidomide, Dexamethasone)
n=4 participants at risk
Pomalidomide: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 5
|
25.0%
1/4 • Number of events 2
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 5
|
50.0%
2/4 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
4/5 • Number of events 23
|
50.0%
2/4 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Edema limbs
|
40.0%
2/5 • Number of events 4
|
50.0%
2/4 • Number of events 5
|
|
General disorders
Fatigue
|
100.0%
5/5 • Number of events 36
|
75.0%
3/4 • Number of events 15
|
|
Infections and infestations
Infections and infestations - Oth spec
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Lymphocyte count decreased
|
80.0%
4/5 • Number of events 25
|
50.0%
2/4 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
100.0%
5/5 • Number of events 18
|
50.0%
2/4 • Number of events 7
|
|
Investigations
Platelet count decreased
|
80.0%
4/5 • Number of events 30
|
50.0%
2/4 • Number of events 7
|
|
Investigations
White blood cell decreased
|
100.0%
5/5 • Number of events 24
|
75.0%
3/4 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 2
|
0.00%
0/4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
5/5 • Number of events 46
|
75.0%
3/4 • Number of events 15
|
|
Nervous system disorders
Tremor
|
0.00%
0/5
|
25.0%
1/4 • Number of events 9
|
|
Psychiatric disorders
Agitation
|
20.0%
1/5 • Number of events 5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • Number of events 2
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
20.0%
1/5 • Number of events 3
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place