S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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