CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis

DISEASE CHARACTERISTICS:

• Symptomatic multiple myeloma

• Previously treated disease meeting one of the following criteria:

  • Have light-chain amyloidosis that has been treated with at least one prior regimen

  • Symptomatic (relapsed or refractory) multiple myeloma

    • Patients must have received 1-3 treatment regimens
    • Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen

• Measurable disease, as defined by 1 of the following:

  • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
  • More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
  • Serum immunoglobulin free light chain (FLC) > 10 mg/dL and an abnormal FLC ratio
  • Measurable soft tissue plasmacytoma, not previously irradiated
  • More than 30% plasma cells in bone marrow
• At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index
• No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid)
• No smoldering myeloma (not applicable for patients with amyloid)

PATIENT CHARACTERISTICS:

• ECOG performance status 0, 1, or 2
• ANC ≥ 1,000/μL
• Platelet count ≥ 75,000/μL
• Creatinine ≤ 2.5 mg/dL

• Not pregnant or nursing

  • Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug
• Negative pregnancy test

• Fertile female patients must use two reliable forms of contraception simultaneously at least 28 days before beginning, during, and at least 28 days after completion of study drug

  • The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, or partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, or cervical cap)
• Fertile male patients must use a latex condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
• Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug
• Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug
• No uncontrolled infection
• No other active malignancy

• No New York Heart Association class III or IV cardiac disease (all patients)

  • Serum troponin T > 0.10 ng/mL (amyloid patients only)
• No known positivity for HIV or active hepatitis infection
• No active deep vein thrombosis or pulmonary embolism that has not been therapeutically anticoagulated
• No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk for participating in the study or confounds the ability to interpret data from the study
• No known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash
• No peripheral neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

• All previous cancer therapy, including chemotherapy and investigational agents, must have been discontinued ≥ 2 weeks prior to study registration
• No radiotherapy ≤ 14 days prior to study registration
• No other concurrent anti-myeloma therapy
• No concurrent radiotherapy, except for palliation of a single painful bone lesion or fracture
• Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone disease
• Willing and able to take aspirin or alternate prophylactic anticoagulation