CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
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|ClinicalTrials.gov Identifier: NCT00091260|
Recruitment Status : Completed
First Posted : September 9, 2004
Results First Posted : February 20, 2017
Last Update Posted : February 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: dexamethasone Drug: lenalidomide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||May 2015|
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 acetate
15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
Other Name: revlimid; CC-5013
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|