Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: cyclophosphamide; dexamethasone; lenalidomide
Intervention description: 300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles); 40 mg administrated by PO (with food)on Days 1, 8, 15 & 22; 25 mg administrated by PO (with food)on Days 1-21
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the
      cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may
      kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving
      lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with
      newly diagnosed multiple myeloma.
    

Eligibility criteria:

        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