Spots Global Cancer Trial Database for Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
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Trial Identification
Brief Title: Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Official Title: Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma
Study ID: NCT00847639
Conditions
Interventions
Study Description
Brief Summary: This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation (HCT). Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from first dose of study drug. Patients will be followed until 28 days from completing the 12th planned cycle of lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first, (14 to 15 months after receiving the allograft) or discontinuation of study drug.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
University of Minnesota Medical Center, Minneapolis, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of Pennsylvania Hospital Center, Philadelphia, Pennsylvania, United States
The University of Texas, M.D. Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Melissa Alsina, MD
Affiliation: H. Lee Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Marcelo Pasquini, MD
Affiliation: CIBMTR/ Medical College of Wisconsin
Role: STUDY_CHAIR
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