Allo Transplant Followed by Lenalidomide and Sirolimus Maintenance in High-Risk Multiple Myeloma (MM)
|ClinicalTrials.gov Identifier: NCT01303965|
Recruitment Status : Terminated (Slow accrual)
First Posted : February 25, 2011
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Sirolimus Drug: Tacrolimus Drug: Lenalidomide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation Followed by Maintenance Therapy With Lenalidomide and Sirolimus in Patients With High-Risk Multiple Myeloma|
|Actual Study Start Date :||February 7, 2011|
|Primary Completion Date :||September 23, 2014|
|Study Completion Date :||July 28, 2017|
U.S. FDA Resources
Experimental: Open Label, Single Arm
Use sirolimus and tacrolimus as GvHD prophylaxis with sirolimus and lenalidomide as post-transplant maintenance
Start on Day -3 and continue for 1 yearDrug: Tacrolimus
Start on Day -3 and begin tapering on Day +100 until Day +180.Drug: Lenalidomide
Start between Day +30 and +120 and continue for 1 year.
- Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of sirolimus, tacrolimus and lenalidomide [ Time Frame: 1 year post transplantation ]Determine the safety of reduced-intensity allogeneic stem cell transplantation using sirolimus and tacrolimus as GvHD prophylaxis with sirolimus and lenalidomide as post-transplant maintenance in an initial Phase I component of the study
- Percent of patients alive and free of progression at 12 months. [ Time Frame: baseline through 1 year post-transplant ]Determine if reduced-intensity allogeneic stem cell transplantation using sirolimus and tacrolimus as GvHD prophylaxis with sirolimus and lenalidomide as post-transplant maintenance can result in 60% of patients with MM alive and free of progression at 12 months, with less than 40% considered unacceptable. This will be completed through the Phase II component of the study.
- Number of subjects with acute and chronic Graft versus Host Disease (GvHD) [ Time Frame: Day 0 through 1 year post transplantation ]
Acute GvHD will be based on the modified Keystone Grading Scale for skin, liver and gastrointestinal symptoms (stage 0-4 for each organ).
Chronic GvHD will be based on Filipovich et al. consensus document (BB&MT 2005) and Akpek et al. chronic GvHD grading system (Blood 2003).
- Number of treatment-related deaths at 100 days and 1 year [ Time Frame: Day +100 and 1 year post transplant ]
- Percentage of donor chimerism as assessed at days +30, +90, +180 and at 12 months post transplant [ Time Frame: +30, +90, +180 and 12 months post transplant ]
- Number of toxicities, frequency and type of infections occurring within the first year [ Time Frame: Day 0 through 1 year post transplantation ]Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Time to engraftment of neutrophils and platelets [ Time Frame: baseline through engraftment ]Engraftment is defined as an absolute neutrophil count (ANC) >/=0.5 x 10^9/L for three consecutive days.
- Time from day 0 to disease progression or death (regardless of cause of death), whichever comes first. [ Time Frame: Day 0 until disease progression ]
- Number of patients with disease progression [ Time Frame: Day 0 until disease progression ]
- Time from day 0 to death from any cause [ Time Frame: Day 0 until death ]
- Number of complete responses (CR), stringent complete responses (sCR), near complete responses (nCR), very good partial responses (VGPR), partial responses (PR) and minimal responses (MR). [ Time Frame: Day 0 until disease progression ]Responses will be based on to International Myeloma Working Group criteria (Durie et al 2006)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303965
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Sherif Farag, MD, PhD||IU Simon Cancer Center|