An Efficacy Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Titre officiel

A Phase 2/3, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Sommaire:

Cette étude vise à comparer l’effet des associations ixazomib + dexaméthasone (ixa+dex) et pomalidomide + dexaméthasone (pom+dex) sur la survie sans progression (SSP) chez des participants atteints de myélome multiple récidivant et/ou réfractaire (MMRR) qui ont reçu au moins 2 traitements antérieurs, y compris la lénalidomide et un inhibiteur de protéasome, et qui présentent une résistance à la lénalidomide, mais pas aux inhibiteurs de protéasome.

Description de l'essai

Primary Outcome:

  • Progression Free Survival (PFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Percentage of Participants with Objective Response Rate (ORR - Partial Response [PR], Very Good Partial Response [VGPR] and Complete Response [CR])
  • Duration of Response (DOR)
  • Time to Response
  • Time to Progression (TTP)
  • Health-Related Quality of Life (HRQOL) based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score
  • HRQOL based on EORTC QLQ-C30 Total Score
  • HRQOL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score
  • HRQOL based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score
  • Health Care Utilization (HU): Number of Medical Encounters
  • HU: Duration of Medical Encounters
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have 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-centre trial will be conducted worldwide. 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 PFS 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 OS every 12 weeks until death or up to 10 years.

Voir cet essai sur ClinicalTrials.gov

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