A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00890552|
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : March 22, 2017
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Amyloidosis||Drug: Lenalidomide Drug: Melphalan Drug: Dexamethasone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 2012|
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
- 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.
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): NCT00890552
|United States, California|
|Stanford University Cancer Institute|
|Stanford, California, United States, 94305|
|Principal Investigator:||Stanley L Schrier, MD||Stanford University|