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A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis


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.

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

- No secondary or familial amyloidosis

- No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR
lytic bone lesions

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- SWOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC > 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)

- AST and ALT ≤ 2 times ULN

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior CC-5013

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability and objective hematologic response with CC-5013 every 3 months

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

David C. Seldin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000385687

NCT ID:

NCT00091260

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118