Revlimid in Transfusion Dependent Patients
NCT01178814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2024-06-24
Summary
This is a prospective trial of Revlimid for subjects who have a blood cell cancer called myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are carried from the genes. The amount of the message tells researchers if the protein it is going to make is high or low. This is known as expression of genes. The purpose of this study is to conduct a prospective trial testing the idea that expression of specific genes can help to predict which patients will respond to study drug administration with Revlimid (lenalidomide).
Conditions
Interventions
- DRUG
-
Revlimid (Lenalidomide)
The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Mark Heaney, MD · Columbia University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-01
- Primary Completion
- 2022-09-01
- Completion
- 2022-12-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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