CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Amyloidosis
Intervention: dexamethasone; pomalidomide
Intervention description: 40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.; 2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Intervention MeSH terms: Dexamethasone; Pomalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 378.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma

Summary:

      RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in
      different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the
      growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with
      dexamethasone may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone
      works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.
    

Eligibility criteria:

        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