CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: dexamethasone; lenalidomide
Intervention description: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.; 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: primary systemic amyloidosis

Summary:

      RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary
      systemic amyloidosis.

      PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without
      dexamethasone in treating patients with primary systemic amyloidosis.
    

Eligibility criteria:

        Inclusion Criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary systemic (AL) amyloidosis

               -  Tissue amyloid deposits or positive fat aspirate

          -  Meets 1 of the following criteria for AL type disease:

               -  Serum or urine monoclonal protein by immunofixation electrophoresis

               -  Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light
                  chain isotype

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  SWOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  White blood count> 3,000/mm^3

          -  Hemoglobin > 8 g/dL

          -  Platelet count > 100,000/mm^3

          -  Absolute neutrophil count > 1,000/mm^3

        Hepatic

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior thalidomide for AL amyloidosis allowed

        Chemotherapy

          -  More than 4 weeks since prior cytotoxic chemotherapy

        Endocrine therapy

          -  Prior steroids for AL amyloidosis allowed

        Radiotherapy

          -  More than 4 weeks since prior radiotherapy

        Surgery

          -  Prior surgery allowed

        Other

          -  Recovered from all prior therapy

        Exclusion Criteria:

          -  No secondary or familial amyloidosis

          -  No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR
             lytic bone lesions

          -  No prior CC-5013

        Renal

          -  No dialysis

        Cardiovascular

          -  No symptomatic cardiac arrhythmia

          -  No oxygen-dependent restrictive cardiomyopathy

        Other

          -  No untreated or uncontrolled infection

          -  No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
             or breast

          -  No other serious medical illness that would preclude study participation

          -  No history of hypersensitivity reaction to thalidomide

          -  HIV negative

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception