Efficacy Study of Revlimid® and Low Dose Continuously Administered Melphalan to Treat High Risk MDS (REMMYDYS)
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|ClinicalTrials.gov Identifier: NCT00744536|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Angiogenesis||Drug: Lenalidomide and melphalan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Revlimid®, and Metronomic Melphalan in the Management of Higher Risk Myelodysplastic Syndromes (MDS) and CMML: A Phase 2 Study"|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Lenalidomide and Melphalan
Lenalidomide + Melphalan both given metronomically
Drug: Lenalidomide and melphalan
Lenalidomide (Revlimid) 10 mg po daily for 21d/28 Melphalan (Melphalan) 2 mg po daily for 21d/28
- Overall Response Rate (RR) (as defined by modified international working group standardized response criteria) [ Time Frame: 3 years ]Overall Response Rate (RR) (as defined by modified international working group standardized response criteria).
- Percent with hematologic improvement [ Time Frame: 3 years ]Percent with hematologic improvement.
- Percent with cytogenetic remission [ Time Frame: 3 years ]Percent with cytogenetic remission.
- Overall, progression-free and leukemia-free-survival [ Time Frame: 3 yrs ]Overall, progression-free and leukemia-free-survival.
- Percent reduction in baseline biomarkers of angiogenesis including: circulating endothelial cells (CEC) and precursors (CEP), plasma and marrow VEGF and VEGFR 1-2 levels [ Time Frame: 3 yrs ]Percent reduction in baseline biomarkers of angiogenesis including: circulating endothelial cells (CEC) and precursors (CEP), plasma and marrow VEGF and VEGFR 1-2 levels.
- Safety (type, frequency, severity, and relationship of adverse events to study therapy) [ Time Frame: 3 yrs ]Safety (type, frequency, severity, and relationship of adverse events to study therapy).
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): NCT00744536
|Sunnybrook Health Sciences Centre, Odette Cancer Center|
|Toronto, Ontario, Canada, M4N3M5|
|Principal Investigator:||Rena J Buckstein, MD FRCPC||Odette Cancer Center|