Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma
The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma|
- Combined Therapy - Number of Participants With Progression Free Survival (PFS) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]The 12-month progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
- Number of Participants With Desired Response [ Time Frame: First measure at 8 weeks ] [ Designated as safety issue: No ]The response rate of older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy
- Number of Participants With Adverse Events [ Time Frame: First measure at 8 weeks ] [ Designated as safety issue: Yes ]The toxicity profile of these lenalidomide based combinations
- Single Agent - Number of Participants With Progressive Free Survival (PFS) [ Time Frame: First measure at 8 weeks ] [ Designated as safety issue: No ]The progression free survival of patients treated with single agent lenalidomide
- Number of Participants With 1 Year Overall Survival (OS) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Other Name: Revlimid®Drug: Prednisone
Other Name: Decadron
Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1. Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the patient's disease is stable after 2 cycles of therapy, the use of an alternate corticosteroid (prednisone) will be added to the lenalidomide therapy they are receiving. Dexamethasone and prednisone are in tablet form and will be taken orally (by mouth). However, if the patient has a minimal response after an additional 2 cycles of lenalidomide therapy, the therapy will be continued until their disease progresses. See the intervention descriptions for further details.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Rachid Baz, M.D.||H. Lee Moffitt Cancer Center and Research Institute|