MLN 9708 With Lenalidomide as Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma Patients
The goal of this clinical research study is to learn if the combination of MLN9708 and Revlimid (also called lenalidomide or CC-5013) can help to control MM as maintenance treatment after an autologous stem cell transplant.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease or prevent the growth of cancer cells.
MLN9708 is designed to block a protein that plays a role in cell function and growth. This may cause cancer cells to die.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma|
- Progression Free Survival (PFS) with Combination of MLN 9708 with Lenalidomide [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Progression free survival (PFS) defined as time from autologous stem cell transplantation (ASCT) to time of clinical progression, death, whichever occurs first or the time of last contact. PFS monitored using the method of Thall et al. (Thall, 2005).
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide + MLN9708
Lenalidomide 10 mg by mouth every day in a 28 day cycle. After three months, the dose may be increased to 15 mg/day at discretion of physician. MLN9708 3 mg by mouth on days 1, 8, 15 in a 28 day cycle. Questionnaire completion on Day 1 of Cycle 1, 2 and beyond.
Starting dose: 10 mg by mouth every day in a 28 day cycle.
Other Names:Drug: MLN9708
3 mg by mouth on days 1, 8, 15 in a 28 day cycle.Radiation: Questionnaires
Questionnaire completion on Day 1 of Cycle 1, 2 and beyond.
Other Name: Surveys
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01718743
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert Orlowski, MD, PHD||M.D. Anderson Cancer Center|