Trial Outcomes & Findings for CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia (NCT NCT00142168)
NCT ID: NCT00142168
Last Updated: 2016-04-21
Results Overview
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
TERMINATED
PHASE2
16 participants
34.3 months
2016-04-21
Participant Flow
Outpatient clinic at DFCI
Symptomatic WM patients requiring therapy
Participant milestones
| Measure |
Lenalidomide and Rituximab
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia
Baseline characteristics by cohort
| Measure |
Lenalidomide and Rituximab
n=16 Participants
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 34.3 monthsPopulation: All enrolled patients
Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.
Outcome measures
| Measure |
Lenalidomide and Rituximab
n=16 Participants
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Time to Progression
|
17.1 months
Interval 2.0 to 34.3
|
PRIMARY outcome
Timeframe: 34.3 monthsPopulation: Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a \> 50% and \> 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having \< 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.
Outcome measures
| Measure |
Lenalidomide and Rituximab
n=12 Participants
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Overall Response
|
8 participants
|
SECONDARY outcome
Timeframe: 34.3 monthsPopulation: Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a \>50% reduction in serum IgM levels.
Outcome measures
| Measure |
Lenalidomide and Rituximab
n=12 Participants
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Major Response Rate
|
4 participants
|
SECONDARY outcome
Timeframe: 34.3 monthsPopulation: Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.
A minor response is defined as having achieved \>25% but less than 50% reduction in serum IgM levels.
Outcome measures
| Measure |
Lenalidomide and Rituximab
n=12 Participants
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Minor Response Rate
|
4 participants
|
Adverse Events
Lenalidomide and Rituximab
Serious adverse events
| Measure |
Lenalidomide and Rituximab
n=16 participants at risk
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
31.2%
5/16 • Number of events 5
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
arrythmia
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
chest pain
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonitis
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Lenalidomide and Rituximab
n=16 participants at risk
Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
8/16 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place