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NCT00567229 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2015-11-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Final Response Rate After 4 Courses of Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior therapy, including radiotherapy * Prior lenalidomide or thalidomide allowed * No prior rituximab
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Biological: rituximab
    2. Drug: lenalidomide
    3. Genetic: microarray analysis
    4. Other: flow cytometry
    5. Other: laboratory biomarker analysis
    label
    Lenalidomide and Rituximab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Lenalidomide and Rituximab
    name
    rituximab
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Lenalidomide and Rituximab
    name
    lenalidomide
    type
    DRUG
  3. arm Group Labels
    1. Lenalidomide and Rituximab
    name
    microarray analysis
    type
    GENETIC
  4. arm Group Labels
    1. Lenalidomide and Rituximab
    name
    flow cytometry
    type
    OTHER
  5. arm Group Labels
    1. Lenalidomide and Rituximab
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Final Response Rate After 4 Courses of Treatment
    time Frame
    2 years
Full study description
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.
detailed Description
OBJECTIVES: Primary * 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. Secondary * 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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
      unicode_code_points
      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice