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Trial record 4 of 2545 for:    "Plasma Cell Neoplasm"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: rituximab Drug: lenalidomide Genetic: microarray analysis Other: flow cytometry Other: laboratory biomarker analysis Phase 2

Detailed Description:



  • To determine the safety and efficacy, as determined by response rate (complete response [CR] + near CR + partial response), of lenalidomide administered with rituximab in patients with relapsed and/or refractory CD20+ multiple myeloma.


  • To assess the effects of this regimen on patient lymphocyte subsets (T, B, and NK cells) in peripheral blood and bone marrow samples from these patients.
  • To perform detailed phenotypic analyses of NK cells in patient blood and bone marrow samples at baseline and post-treatment.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for at least 4 courses. Patients also receive rituximab IV once weekly in weeks 2-5 and in week 13. Patients with stable disease then receive rituximab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Peripheral blood samples are collected at baseline, and after courses 2 and 4. Samples are examined by flow cytometry for lymphocyte subset analysis (T-, B-, and NK-cell percentages and absolute numbers) and NK-cell phenotyping (CD16, CD56, NKG2D expression). Samples are also examined by immunologic assays of isolated peripheral blood mononuclear cells. Bone marrow aspirate samples are also collected at baseline and after course 2. Bone marrow mononuclear cells are isolated and evaluated by CD138+ plasma cell selection, ex vivo antibody-dependent cellular cytotoxicity assays, and bone marrow lymphocyte subset analysis.

After completion of study therapy, patients are followed at 30 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Lenalidomide and Rituximab for Patients With Relapsed and/or Refractory CD20+ Multiple Myeloma
Study Start Date : November 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
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.
Biological: rituximab
Drug: lenalidomide
Genetic: microarray analysis
Other: flow cytometry
Other: laboratory biomarker analysis

Primary Outcome Measures :
  1. Final Response Rate After 4 Courses of Treatment [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed CD20+ multiple myeloma

    • CD20+ disease defined as co-expression of CD20 on ≥ 25% of the clonal plasma cell population as defined by immunohistochemical or flow cytometric staining of a bone marrow or plasmacytoma specimen obtained at study entry

      • For flow cytometry, this is determined by calculating the frequency of CD20+ CD138+ double-positive cells within the total CD138+ plasma cell population
      • For immunohistochemistry, this is determined by dual staining for CD20 and the involved clonal light chain (kappa or lambda), with a determination of the percent double-positive (≤ 25% or ≥ 25%)
  • Symptomatic multiple myeloma that has relapsed or progressed after at least 1 prior anti-myeloma therapeutic regimen


  • ECOG performance status 0-2
  • Life expectancy > 16 weeks (4 months)
  • ANC ≥ 1,500/μL (unless low ANC due to multiple myeloma)
  • Platelets ≥ 100,000/μL (unless low platelets are due to multiple myeloma)
  • Serum bilirubin ≤ 2.0 mg/dL
  • AST, ALT, and alkaline phosphatase < 3 times upper limit of normal
  • Serum creatinine ≤ 2.5 mg/dL
  • Able to understand the investigational nature of lenalidomide and rituximab combination therapy and to give informed consent
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception at least 28 days before, during, and for at least 28 days after completion or discontinuation of study treatment
  • Able to take acetylsalicylic acid (ASA) (325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
  • Prior malignancies with a disease free interval of ≥ 5 years allowed
  • No history of thromboembolic disease within the past 6 months, regardless of anticoagulation
  • No myocardial infarction within the past 6 months
  • No New York Hospital Association class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No active hepatitis B or C infection
  • No HIV 1or 2 positivity
  • No acute ischemia or active conduction system abnormalities as evidenced by ECG
  • No history of hypersensitivity reactions to lenalidomide, thalidomide, or rituximab
  • No other medical condition or laboratory evaluation that, in the treating physician's or principal investigators' opinion, makes the patient unsuitable to participate in this clinical trial
  • No concurrent active malignancy other than nonmelanoma skin cancers or carcinoma-in-situ of the cervix


  • At least 3 weeks since prior therapy, including radiotherapy
  • Prior lenalidomide or thalidomide allowed
  • No prior rituximab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567229

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Hani Hassoun, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Heather Landau, MD Memorial Sloan Kettering Cancer Center

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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00567229     History of Changes
Obsolete Identifiers: NCT00590486
Other Study ID Numbers: Mskcc 07-070
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2007    Key Record Dates
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
refractory multiple myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors