A Study of Oral Ixazomib Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

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

Summary:

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 newly diagnosed multiple myeloma (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 stem-cell transplantation (SCT).

Trial Description

Primary Outcome:

  • Progression Free Survival (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)
  • Second Progression-Free Survival (PFS2)
  • Time to End of the Next Line of Therapy after Study Treatment
  • 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
  • Overall (OS) Survival in a High-Risk Population
  • Progression Free Survival (PFS) in a High-Risk Population
  • Percentage of Participants with Serious Adverse Events and Adverse Events (AEs)
  • Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ-C30
  • Number of Participants with Any Markedly Abnormal Standard Safety Laboratory Values
  • Correlation between Frailty Status and Progression Free Survival (PFS) and Overall Survival (OS)
  • Pharmacokinetic Parameter: Plasma Concentration of Ixazomib
  • Time to Resolution of Peripheral Neuropathy (PN) Events
  • Time to Improvement of Peripheral Neuropathy (PN) Events
The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have newly diagnosed multiple myeloma (NDMM) who have had a major positive response to initial therapy and have not undergone stem cell transplantation (SCT). This study will look at the effect of ixazomib citrate has on the length of time that participants are free of disease progression and their overall survival. The study will enroll approximately 761 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient 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 up to 24 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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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society