Clinical Trials Search
Clinical Trial 18217
Interventions:Alkeran (Melphalan); Bortezomib; FK506 (Tacrolimus); Ixazomib (Ninlaro); Melphalan; Not Applicable; PS-341 (Bortezomib); Placebo; Tacrolimus; Velcade (Bortezomib); fludarabine (Fludarabine phosphate); methotrexate
Study Type: Treatment
Phase of Study: Phase II
- Taiga Nishihori
Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma
The purpose of this study to learn if adding Ixazomib to the participant's maintenance treatment (chemotherapy) works better to control their disease than placebo (pill that doesn't have any drugs, like a sugar pill).
The primary objective of this randomized trial is to compare progression free survival from randomization as a time to event endpoint between patients randomized to ixazomib maintenance or placebo. Secondary objectives are to describe for each treatment arm: rates of grade II-IV and III-IV GVHD, chronic GVHD, best disease response rates, disease progression, transplant related mortality, overall survival, rates of Grade 3 or higher toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, incidence of infections, and health-related quality of life.