Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

OBJECTIVES:

Primary

• Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

• Assess the toxicity of this regimen in these patients.
• Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Newly diagnosed disease
• Symptomatic disease
• Measurable or evaluable disease, defined by ≥ 1 of the following criteria:

• Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
• Monoclonal protein > 200 mg by 24-hour urine electrophoresis
• Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
• Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
• Measurable soft tissue plasmacytoma not previously irradiated
• No monoclonal gammopathy of undetermined significance or smoldering myeloma

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3
• Hemoglobin ≥ 8.0 g/dL
• Creatinine ≤ 2.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy
• No uncontrolled infection
• No other active malignancy
• No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• No NYHA class III-IV congestive heart failure
• No untreated active deep vein thrombosis

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since prior radiotherapy for solitary plasmacytoma
• Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed
• No prior cytotoxic chemotherapy
• No prior corticosteroids (except for treatment of a nonmalignant disorder)
• Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed
• No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture