Multiple Myeloma Clinical Trial
CC-5013 With or Without Dexamethasone in Treating Patients With 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.
Full Description
OBJECTIVES:
Primary
Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis.
Determine the objective hematologic response rate in patients treated with this drug.
Determine amyloid organ disease response in patients treated with this drug.
Secondary
Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone.
Determine the toxicity of CC-5013 in combination with dexamethasone in these patients.
OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.
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
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There is 1 Location for this study
Boston Massachusetts, 02118, United States
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