Determining the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma
|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: NCT02168101|
Recruitment Status : Active, not recruiting
First Posted : June 20, 2014
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: MLN9708||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study to Determine the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma, Followed by an Expansion Phase at the Maximum-Tolerated Dose (MTD) - A Phase II Study|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. Up to 18 patients will be enrolled in a dose-escalation phase to determine the maximum tolerated dose (MTD). Once the MTD is determined, an additional 20 patients will be enrolled in an expansion phase at that dose.
Dose-Escalation Phase: MLN9708 will be administered orally (PO) as monotherapy. Dosing will start at 2.3 mg. If acceptable tolerability is demonstrated, escalations will be made to 3 mg and to a maximum-planned dose (MPD) of 4 mg.
Expansion Phase: An additional 20 patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive MLN9708 orally on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Dose-Escalation Phase: MLN9708 will be administered orally (PO) as monotherapy.
Expansion Phase: An additional 20 patients will receive MLN9708 at the MTD
Other Name: ixazomib
- Highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (28 days) of therapy. [ Time Frame: Days 1, 4, 8 and 15 of Cycle 1 (28 days) ]The maximum tolerated dose (MTD) of study drug will be determined as the number of patients experiencing a Grade 3 or Grade 4 adverse event utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0
- Progression-Free Survival at 2 years post-maintenance therapy [ Time Frame: every 8 weeks for approximately 24 weeks then every 3 months thereafter for 2 years ]Defined as the time from Day 1 of study drug administration to disease progression as defined by International Myeloma Working Group Uniform Response Criteria, or death on study. Patients who discontinue study treatment prior to progression will be followed every 3 months during years 1 and 2 for survival.
- Overall Survival at 2 years post-allogeneic stem cell transplant (ASCT) [ Time Frame: every 8 weeks for approximately 24 weeks after ASCT, then every 3 months thereafter for 2 years. ]Defined as the time from Day 1 of study drug administration to death on study.
- Number of subjects with incidence of graft-versus-host disease (GVHD) [ Time Frame: every 28 days, up to 24 months ]Assessed from date of randomization until date of first documented progression, or date of death from any cause, up to 24 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168101
|United States, Colorado|
|Colorado Blood Cancer Institute|
|Denver, Colorado, United States, 80218|
|United States, Ohio|
|Oncology Hematology Care|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Texas Transplant Institute|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Carlos Bachier, MD||Texas Transplant Institute|