Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis (MRD)
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis|
- Hematologic response rate as measured by standard criteria [ Time Frame: one year ] [ Designated as safety issue: No ]measured by standard criteria
- Organ response [ Time Frame: one year ] [ Designated as safety issue: No ]
- Safety (i.e., type, frequency, severity, and relationship of adverse events to study treatment) [ Time Frame: within 100 days of infusion ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
40 mg/QD once weekly
Other Name: DecadronDrug: lenalidomide
10 mg/day D1-21
Other Name: revlimid, cc-5013Drug: melphalan
5 mg/m2 D1-4
Other Name: alkeran
- To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
- To determine the hematologic response rate in patients treated with this regimen.
- To assess organ response in patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679367
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||David C. Seldin, MD, PhD||Boston Medical Center|