Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma (07-REV)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma|
- To determine tolerability and safety profile of a maximum of 12 cycles or 12 months from first dose (which ever comes first) of lenalidomide maintenance therapy post allogeneic hematopoietic cell transplantation for high risk multiple myeloma. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To estimate the incidences of ≥ grade 3 adverse events, graft failure, infections, treatment-related mortality (TRM) and incidence and severity of acute and chronic GVHD after initiation of lenalidomide. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
- To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT. [ Time Frame: 13 Months ] [ Designated as safety issue: Yes ]
- To determine time to disease progression and overall survival after lenalidomide. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Lenalidomide maintenance therapy will start within 60 to 90 days after allogeneic HCT at a starting dose of 10mg PO once daily.
Dose escalation and de-escalation are performed depending on tolerability of lenalidomide.
The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days).
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Minnesota|
|University of Minnesota Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, Pennsylvania|
|University of Pennsylvania Hospital Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|The University of Texas, M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98195|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Melissa Alsina, MD||H. Lee Moffitt Cancer Center|
|Study Chair:||Marcelo Pasquini, MD||CIBMTR/ Medical College of Wisconsin|