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

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma Read More

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