A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Newly diagnosed multiple myeloma, meeting the following criteria:

- Symptomatic disease

- Previously untreated disease

- Measurable or evaluable disease, defined by ≥ 1 of the following:

- Serum monoclonal protein ≥ 1.0 g/dL

- Monoclonal protein > 200 mg by 24-hour urine electrophoresis

- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum
immunoglobulin kappa:lambda free light chain ratio

- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

- Measurable soft tissue plasmacytoma, not previously radiated

- No monoclonal gammopathy of unknown significance or asymptomatic myeloma

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain)

- ANC ≥ 1,500/μL

- Platelet count ≥ 75,000/μL

- Creatinine ≤ 2.0 mg/dL

- Total bilirubin ≤ 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective forms of contraception 28 days prior to, during
and 28 days after study treatment

- Registered into the RevAssist® program and willing to comply with program
requirements

- Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight
heparin

- Willing to provide mandatory blood and bone marrow samples

- Willing to return for follow up

- No uncontrolled infection

- No NYHA class III or IV heart failure

- No active deep vein thrombosis that has not been therapeutically anticoagulated

- No known hypersensitivity to thalidomide

- No known HIV positivity

- No known hepatitis type A, B, or C infection

- No other prior active malignancy within the past 2 years, except currently treated
basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
or breast

- No development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since prior radiotherapy for solitary plasmacytoma

- More than 28 days since other prior experimental drug or therapy

- Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed

- No prior lenalidomide

- No prior cytotoxic chemotherapy

- No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease

- Prior corticosteroid for nonmalignant disease allowed

- Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent)

- Concurrent palliative radiotherapy for bone pain or fracture allowed

- No other concurrent anticancer agents or treatments