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 ]
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): NCT00981708
|Alexandra Hospital , Department of Clinical Therapeutics|
|Athens, Attica, Greece, 115 28|
|Principal Investigator:||Meletios A Dimopoulos, MD||University of Athens, School of Medicine|