Overview

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