A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Official Title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation


The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

Trial Description

Primary Outcome:

  • PFS
Secondary Outcome:
  • Overall Survival (OS)
  • Percentage of Participants who Achieve or Maintain any Best Response Category During the Treatment Period
  • Time to Progression (TTP)
  • Progression Free Survival 2 (PFS2)
  • Time to Next Line Therapy (TTNT)
  • Time to end of the Next-line of Therapy After Study Treatment
  • Duration of Next-line Therapy
  • Percentage of Participants Who Develop A New Primary Malignancy
  • Percentage of Participants with Conversion from Minimal Residual Disease (MRD) Positive to MRD Negative, or the Maintenance of MRD Negativity
  • Correlation of MRD Status With PFS and OS
  • OS in a High-risk Population
  • PFS in a High-risk Population
  • Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Percentage of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
  • Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • Number of Participants with any Markedly Abnormal Standard Safety Laboratory Values
  • Correlation between Frailty Status and PFS and OS
  • Pharmacokinetic Parameter: Plasma Concentration of Ixazomib
  • Time to Resolution of Peripheral Neuropathy (PN) Events
  • Time to Improvement of PN Events
The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow PD and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival. The study will enroll approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
  • Ixazomib citrate 3 mg
  • Placebo (dummy inactive pill)
  • this is a capsule that looks like the study drug but has no active ingredient All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 76 to 104 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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