Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)
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|ClinicalTrials.gov Identifier: NCT00981708|
Recruitment Status : Unknown
Verified January 2014 by Meletios A. Dimopoulos, University of Athens.
Recruitment status was: Active, not recruiting
First Posted : September 22, 2009
Last Update Posted : January 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Amyloidosis||Drug: Lenalidomide, Dexamethasone and Cyclophosphamide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||February 2015|
Lenalidomide, Dexamethasone and cyclophosphamide
Drug: Lenalidomide, Dexamethasone and Cyclophosphamide
Lenalidomide capsules on days 1 to 21. the dose starts at 5 mg/day up to 25 mg/day.
Dexamethasone tablets on days 1 to 4. Dose 20 mg per day.
Cyclophosphamide tablets on days 1 to 10. The dose starts at 50 mg per day up to 100 mg per day.
The cycle is to be repeated every 28 days (4 weeks)
- To assess the maximum tolerated dose of lenalidomide and cyclophosphamide and assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis. [ Time Frame: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response ]
- To assess the toxicity of Cyclophosphamide/Dexamethasone plus lenalidomide combination in patients with AL amyloidosis and organ response rate [ Time Frame: Monthly for toxicity and every 3-6 months for organ response ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981708
|Alexandra Hospital , Department of Clinical Therapeutics|
|Athens, Attica, Greece, 115 28|
|Principal Investigator:||Meletios A Dimopoulos, MD||University of Athens, School of Medicine|