CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0737 (clinicaltrials.gov NCT No: NCT01029262)
Title:A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS PLACEBO IN SUBJECTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO IPSS LOW OR INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROMES WITHOUT DELETION 5Q(31) AND UNRESPONSIVE OR REFRACTORY TO ERYTHROPOIESIS-STIMULATING AGENTS
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:Lenalidomide
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if patients with low risk
or intermediate-1 risk MDS will need fewer blood transfusions if they take
Revlimid® (lenalidomide). Lenalidomide will be compared to a placebo. A
placebo is a substance that looks like the study drug but has no active
ingredients. The safety of lenalidomide will also be studied.

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Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:Lenalidomide
Treatment Location:Both at MDACC & Community Programs (CCOP/Network)
Estimated Length of Stay in Houston:NA
Supported By:Celgene Corporation
Return Visit:Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 113, 141, 169 and every 28
days (all times are +/- 3 days) while on treatment then every 3 months.
Home Care:Self-medicated


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Physician Name:Guillermo Garcia-Manero
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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