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Trial record 4 of 2517 for:    "Plasma Cell Neoplasm"

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

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ClinicalTrials.gov Identifier: NCT00567229
Recruitment Status : Terminated (Lack of Accrual)
First Posted : December 4, 2007
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Biological: rituximab
Drug: lenalidomide
Genetic: microarray analysis
Other: flow cytometry
Other: laboratory biomarker analysis
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide and Rituximab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Lenalidomide and Rituximab
Hide Arm/Group Description 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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
1.Primary Outcome
Title Final Response Rate After 4 Courses of Treatment
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide and Rituximab
Hide Arm/Group Description:
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 Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
Stable Disease (SD) 2
Progression of Disease (POD) 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide and Rituximab
Hide Arm/Group Description 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.
All-Cause Mortality
Lenalidomide and Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide and Rituximab
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Respiratory, thoracic and mediastinal disorders   
Pulmonary/upper respiratory  1  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide and Rituximab
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  1/3 (33.33%)  1
PT INR  1  1/3 (33.33%)  1
Leukocytes (total WBC)  1  2/3 (66.67%)  2
Lymphopenia  1  1/3 (33.33%)  1
Neutrophils/granulocytes  1  3/3 (100.00%)  3
Gastrointestinal disorders   
Constipation  1  1/3 (33.33%)  1
Nervous system disorders   
Neuropathy: sensory  1  2/3 (66.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Hani Hassoun
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-3228
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00567229     History of Changes
Obsolete Identifiers: NCT00590486
Other Study ID Numbers: Mskcc 07-070
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07070
First Submitted: December 1, 2007
First Posted: December 4, 2007
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015