Lenalidomide With or Without 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: dexamethasone; lenalidomide
Intervention description: Dose: -40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
If after 3 cycles, a partial response is not achieved on lenalidomide alone, dexamethasone 10 mg weekly will be added, and the weekly dexamethasone dose will be increased by 10 mg each cycle to a maximum of 40 mg weekly, as long as a partial response is not achieved. If a partial response is achieved at a dose of dexamethasone less than 40 mg weekly, patients will continue on that dose. If progression at any time, increase dexamethasone to 40 mg weekly. Patient will go off study only when progression is documented while receiving 40 mg/week of dexamethasone or the maximum tolerated dose of dexamethasone (if prior dose reductions have been implemented for toxicity). Increases in dexamethasone dose are to be made only at the initiation of a cycle.
If progression at any time while on lenalidomide alone (first 3 cycles), add dexamethasone 40 mg weekly.; 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
Lenalidomide alone will be administered for the first 3 cycles, then in combination with dexamethasone as needed (described).
Intervention MeSH terms: Dexamethasone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking
      blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well lenalidomide works with or without
      dexamethasone in treating patients with newly diagnosed multiple myeloma.
    

Eligibility 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