CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis|
- Number of Patients Removed From Study Treatment Due to Toxicities [ Time Frame: 1 year ]
- Number of Patients With Hematologic Response With Single-agent CC-5013 [ Time Frame: 3 months ]
Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.
Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.
For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.
For patients with an elevated serum free light chain assay, a reduction of 50% or more.
- Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response [ Time Frame: 1 year ]
|Study Start Date:||January 2004|
|Study Completion Date:||May 2015|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
Other Name: dexamethasone acetateDrug: lenalidomide
15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
Other Name: revlimid; CC-5013
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091260
|United States, Massachusetts|
|Cancer Research Center at Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||David C. Seldin, MD, PhD||Boston Medical Center|