Clinical trial NCT00064038 (phase 3, status: completed)
Conditions: multiple myeloma, plasma cell neoplasm
ICD codes: C90.01, C90.02, C90.00, C96.20, C96.29, D47.09
Drugs: dexamethasone, lenalidomide
SMILES: C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
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