Multiple Myeloma Clinical Trial
Official title:
A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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