Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis
The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with melphalan and dexamethasone that can be given to patients with AL amyloidosis. The safety of this drug combination will also be studied.
Pomalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other chemotherapy to treat cancer.
Planned Phase I/II Study terminated early during Phase I portion without continuation to Phase II.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase I|
- Maximum Tolerated Dose (MTD) of Pomalidomide with Melphalan and Dexamethasone (PMD). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Maximum tolerated dose defined as highest dose level at which less than 33% of patients experienced dose-limiting toxicities. Dose-limiting toxicities defined as (grade 4 neutropenia lasting more than 7 days despite G-CSF administration, any other grade 4 hematologic toxicity, any grade 3 non-hematologic toxicity, or a new cycle delay beyond a maximum of 4 weeks) in less than 33% of patients during the first cycle of therapy.
- Complete Response (CR) Rate [ Time Frame: Response evaluated after a minimum of 2 cycles and a maximum of 6 cycles of 28-day treatment ] [ Designated as safety issue: No ]CR Rate is number of participants with CR out of total study participants. Complete response defined using treatment response in primary systemic amyloidosis from the 10th International Symposium on Amyloid and Amyloidosis where CR: Serum and urine negative for a monoclonal protein by immunofixation; free light chain ratio normal; marrow <5% plasma cells.
|Study Start Date:||January 2014|
|Study Completion Date:||February 2016|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: Pomalidomide + Melphalan + Dexamethasone
Starting dose of Pomalidomide 1 mg/day by mouth on days 1-21. Melphalan 9 mg/m2 by mouth on days 1-4 of every 28-day cycle. Dexamethasone 40 mg/day by mouth on days 1-4. Questionnaires completed at different time points during study.
Phase I: Starting dose of Pomalidomide 1 mg/day by mouth on days 1-21 of a 28 day cycle.
Phase II: Starting dose of Pomalidomide maximum tolerated dose from Phase I.
Phase I and II: 9 mg/m2 by mouth on days 1-4 of a 28-day cycle.
Other Name: AlkeranDrug: Dexamethasone
Phase I and II: 40 mg/day by mouth on days 1-4 of a 28 day cycle.
Other Name: DecadronBehavioral: Questionnaires
Questionnaires about the feeling in hands and quality of life completed at different time points during the study.
Other Name: Surveys
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01807286
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert Orlowski, MD, PHD||M.D. Anderson Cancer Center|