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A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Millennium Pharmaceuticals, Inc.
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will compare the efficacy and safety in participants who take ixazomib and dexamethasone to pomalidomide and dexamethasone. It is an open-label, phase 2 study that, on the basis of a prespecified go/no-go decision rule, will progress to a phase 3 registrational study.
The study will enroll approximately 300 patients. Participants will receive:
•Ixazomib 4 mg + dexamethasone 20 mg (or 10 mg if participant is aged ≥75 years) OR
•pomalidomide 4 mg + dexamethasone 40 mg (or 20 mg if participant is aged ≥75 years)
All participants will be asked to take either ixazomib plus dexamethasone (in cases where only 4 mg tablets for dexamethasone are available, the following dexamethasone schedule is recommended for participants aged ≥75 years: 12 mg dexamethasone will be given on Days 1, 8, 15, and 22 of every 28-day cycle; and 8 mg dexamethasone will be given on Days 2, 9, 16, and 23 of every 28-day cycle) or pomalidomide 4 mg + dexamethasone 40 mg at recommended doses.
This multi-center trial will be conducted world wide. The overall time to participate in this study is approximately 63 months if the phase 3 portion of the study is completed. Alternatively, if the no-go criteria are met during the phase 2 portion, the study will be completed approximately 22 to 29 months after the first participant enters the study.
Participants will make multiple visits to the clinic, and will be contacted for progression free survival follow-up, in case of study drug discontinuation for up to 7 years from first dose administration. After disease progression, participants will be followed-up for overall survival every 12 weeks until death or up to 10 years.