A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis|
- Hematologic Response Rate [ Time Frame: 8 weeks ]At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).
- Overall Survival (OS) [ Time Frame: 12 months ]Participants alive 12 months after starting MDR treatment.
- Event-free Survival (EFS) [ Time Frame: 12 months ]Assessed as the median value for EFS 12 months after starting MDR treatment
- Duration of Response [ Time Frame: 32 months ]Assessed as the median value for the time from first partial response until progression; death; or last follow-up.
|Study Start Date:||April 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment).
Lenalidomide is a a derivative of thalidomide.
Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle.
Other Names:Drug: Melphalan
Melphalan is a phenylalanine derivative of mechlorethamine.
Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle
Other Names:Drug: Dexamethasone
Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication.
Orally-administered dexamethasone 40 mg orally once weekly of a 28-day cycle
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890552
|United States, California|
|Stanford University Cancer Institute|
|Stanford, California, United States, 94305|
|Principal Investigator:||Stanley L Schrier, MD||Stanford University|