CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vaishali Sanchorawala
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide

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