Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: rituximab; lenalidomide; microarray analysis; flow cytometry; laboratory biomarker analysis
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: refractory multiple myeloma

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.
    

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