Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: cyclophosphamide; dexamethasone; lenalidomide
Intervention description: 300 mg/m^2 days 1, 8 & 15 of a 28 day cycle taken orally with food; 40 mg weekly taken orally; 15 mg daily days 1-21 of a 28 day cycle taken orally with food
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: primary systemic amyloidosis

Summary:

      RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in
      different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as
      cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma
      cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide
      together with cyclophosphamide and dexamethasone may be an effective treatment for primary
      systemic amyloidosis.

      PURPOSE: This phase II trial is studying how well giving lenalidomide together with
      cyclophosphamide and dexamethasone works in treating patients with primary systemic
      amyloidosis.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histochemical diagnosis of AL amyloidosis based on detection of green birefringent
             material in Congo red-stained tissue specimens by polarizing microscopy

          -  Measurable disease, as defined by one of the following:

               -  Serum monoclonal protein ≥ 1.0 g by serum electrophoresis

               -  Urine monoclonal protein > 200 mg by 24-hour urine electrophoresis

               -  Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum
                  immunoglobulin kappa to lambda free light chain ratio

          -  Symptomatic organ involvement with amyloid to justify therapy

               -  May include liver involvement, cardiac involvement, renal involvement, grade 1
                  peripheral neuropathy, or soft tissue involvement

               -  Must have more than skin purpura or carpal tunnel syndrome

          -  No amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as only
             evidence of disease

             - Vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not
             indicative of systemic amyloidosis

          -  No clinically overt multiple myeloma (i.e., monoclonal BMPC > 30%, bone lesions, or
             hypercalcemia)

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,000/μL

          -  Platelet count ≥ 75,000/μL

          -  Creatinine < 3.0 mg/dL

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use two acceptable methods of contraception for ≥ 28 days prior
             to, during, and for ≥ 28 days after completion of study treatment

          -  No nursing during and for ≥ 28 days after completion of study treatment

          -  No blood, semen, or sperm donation during and for ≥ 28 days after completion of study
             treatment

          -  No malignancies within the past 5 years except treated basal cell or squamous cell
             carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

          -  No neuropathy ≥ grade 2, defined as motor neuropathy (symptomatic weakness interfering
             with function, but not interfering with activities of daily living [ADL]) or sensory
             neuropathy (sensory alteration or paresthesia [including tingling], interfering with
             function, but not interfering with ADL)

          -  No uncontrolled infection

          -  No syncope within the past 30 days

          -  No known hypersensitivity to thalidomide, including desquamating rash with thalidomide
             in the past

          -  No known seropositivity for HIV

          -  No active hepatitis A, B, or C

          -  No New York Heart Association class III or IV heart disease

          -  No venous thromboembolic event within the past 42 days

          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation - Patients
             intolerant to aspirin may use low molecular weight heparin

        PRIOR CONCURRENT THERAPY:

          -  No prior lenalidomide

          -  More than 2 weeks since prior and no other concurrent anticancer agents or treatments

          -  More than 4 weeks since prior experimental agents

          -  No other concurrent corticosteroids except chronic steroids (maximum dose 20 mg/day of
             prednisone equivalent) for disorders other than amyloidosis (e.g., adrenal
             insufficiency or rheumatoid arthritis)