Clinical trial NCT00567229 (phase 2, status: terminated)
Conditions: multiple myeloma and plasma cell neoplasm
ICD codes: C96.20, C96.29, D47.09
Drugs: lenalidomide
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Reason stopped: 
    lack of accrual
  
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