Trial Outcomes & Findings for Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma (NCT NCT00567229)

Last Updated: 2015-11-20

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

2 years

Results posted on

2015-11-20

Participant milestones
Measure	Lenalidomide and Rituximab This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma

Baseline characteristics by cohort
Measure	Lenalidomide and Rituximab n=3 Participants This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

Timeframe: 2 years

Outcome measures
Measure	Lenalidomide and Rituximab n=3 Participants This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
Final Response Rate After 4 Courses of Treatment Stable Disease (SD)	2 participants
Final Response Rate After 4 Courses of Treatment Progression of Disease (POD)	1 participants

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events
Measure	Lenalidomide and Rituximab n=3 participants at risk This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory	33.3% 1/3 • Number of events 1

Other adverse events
Measure	Lenalidomide and Rituximab n=3 participants at risk This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders PT INR	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Leukocytes (total WBC)	66.7% 2/3 • Number of events 2
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • Number of events 1
Nervous system disorders Neuropathy: sensory	66.7% 2/3 • Number of events 2
Blood and lymphatic system disorders Neutrophils/granulocytes	100.0% 3/3 • Number of events 3

Memorial Sloan Kettering Cancer Center

Phone: 212-639-3228