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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00567229
Phase
PHASE2
Status
Terminated

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • lenalidomide — DRUG
  • microarray analysis — GENETIC
  • flow cytometry — OTHER
  • laboratory biomarker analysis — OTHER

Study Details

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may be an effective treatment for multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving lenalidomide together with rituximab and to see how well it works in treating patients with recurrent or refractory multiple myeloma.

Key Dates

Start date
Nov 30, 2007
Status verified
Oct 2015
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Final Response Rate After 4 Courses of Treatment [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-

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By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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