S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
Condition: Multiple Myeloma; Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: dexamethasone; lenalidomide; placebo
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer
      cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple
      myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is
      more effective with or without lenalidomide in treating multiple myeloma.

      PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see
      how well they work compared to dexamethasone alone in treating patients with previously
      untreated stage I, stage II, or stage III multiple myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Previously untreated multiple myeloma

               -  Stage I, II, or III disease by the International Staging System

          -  Measurable M-protein as defined by 1 of the following:

               -  Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or
                  immunoelectrophoresis

               -  Urinary M-protein excretion at least 200 mg/24 hours

          -  No nonsecretory multiple myeloma

          -  Not planning to undergo future autologous stem cell transplantation

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of
             disability

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count at least 80,000/mm^3*

          -  Absolute neutrophil count at least 1,000/mm^3*

          -  Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due to
             greater than 50% marrow involvement by myeloma on biopsy

        Hepatic

          -  AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this
             range are allowed at the investigator's discretion

        Renal

          -  Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed
             at the investigator's discretion

        Cardiovascular

          -  No New York Heart Association class III or IV heart failure

          -  No myocardial infarction within the past 6 months

          -  No poorly controlled hypertension

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception for 4 weeks before, during, and for
             4 weeks after study treatment

               -  Female patients must use 2 reliable forms of contraception simultaneously

               -  Male patients must use effective barrier contraception

          -  No uncontrolled active infection requiring IV antibiotics

          -  No poorly controlled diabetes mellitus that would preclude ability to take oral
             glucocorticoids

          -  No other serious medical condition that would preclude study participation

          -  No psychiatric illness that would preclude study participation

          -  No other malignancy within the past 3 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin
             subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except
             if already on therapeutic anticoagulant medication

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior interferon or thalidomide

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Prior high-dose dexamethasone allowed provided duration of administration was no more
             than 4 days

        Radiotherapy

          -  Prior localized radiotherapy allowed provided it was not to the sole site of evaluable
             disease

        Surgery

          -  Not specified

        Other

          -  No prior treatment for clinically significant ventricular cardiac arrhythmias

          -  Concurrent bisphosphonates allowed