A Phase 3, Multicenter, Placebo-Controlled Study to Compare the Efficacy and Safety of Lenalidomide vs. Placebo in Subjects With Transfusion Dependent Anemia Due to Low or Intermediate Risk MDS and Unresponsive to ESA Therapies
18 Years
N/A
Both
Anemia
Trial Information
A Phase 3, Multicenter, Placebo-Controlled Study to Compare the Efficacy and Safety of Lenalidomide vs. Placebo in Subjects With Transfusion Dependent Anemia Due to Low or Intermediate Risk MDS and Unresponsive to ESA Therapies
Inclusion Criteria:
- 18 years or older
- Diagnosis of low or intermediate-1 risk MDS with any chromosome karyotype except del
5q[31]
- Anemia that requires red blood cell transfusions
- Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level >
500 mU/mL
- ECOG Performance Status ≤ 2
- Must agree to follow pregnancy precautions as required by the protocol.
- Must agree to receive counseling related to teratogenic and other risks of
lenalidomide
- Must agree not to donate blood or semen
- Must be willing to consent to two or more bone marrow aspirate procedures to be
completed during study
Exclusion Criteria:
- Subjects previously receiving immunomodulating or immunosuppressive agents, or
epigenetic or DNA modulation agents
- Allergic reaction to thalidomide
- Renal insufficiency (CrC1<40 mL/min by Cockroft-Gault method)
- Prior history of cancer, other than MDS, unless the subject has been free of the
disease for ≥ 5 years. (Basal cell carcinoma of the skin, Carcinoma in situ of the
cervix, or stage T1a or T1b prostate cancer is allowed)
- Absolute neutrophil count < 500/uL
- Platelets < 50,000/uL
- AST or ALT > 3X upper limit of normal
- Uncontrolled hyperthyroidism or hypothyroidism
- Significant neuropathy
- Prior stem cell transplantation
- Anemia due to reasons other than MDS
- History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years
- Significant active cardiac disease within the past 6 months
- Known HIV infection; known Hepatitis C infection or active Hepatitis B infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of subjects that become transfusion independent. Proportion of subjects with an erythroid differentiation gene expression signature that become transfusion independent.
Outcome Time Frame:
Up to 4 years for each subject (likely to be 6 months to 2 years)
Safety Issue:
No
Principal Investigator
Bouchra Benettaib, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Food and Drug Administration
Study ID:
CC-5013-MDS-005
NCT ID:
NCT01029262
Start Date:
November 2009
Completion Date:
December 2018
Related Keywords:
- Anemia
- Myelodysplastic Syndromes
- MDS
- transfusion dependent anemia
- Erythropoiesis stimulating agents
- non-del 5q
- Anemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Medical College of Wisconsin, Froedtert Hospital | Milwaukee, Wisconsin 53226 |
| (853) University of California Los Angeles Medical Center | Los Angeles, California 90095 |
| (858) Southern Illinois Hematology Oncology | Centralia, Illinois 62801 |
| (851) Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| (857) Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| (852) Columbia University Medical Center | New York, New York 10032 |
| (855) University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |
