MLN 9708 With Lenalidomide as Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01718743|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : February 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: Lenalidomide Drug: MLN9708 Radiation: Questionnaires||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
U.S. FDA Resources
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
- Progression Free Survival (PFS) with Combination of MLN 9708 with Lenalidomide [ Time Frame: 6 months ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718743
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Krina Patel, MD||M.D. Anderson Cancer Center|