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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Ixazomib (Primary)
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms TOURMALINE-MM4
  • Sponsors Takeda Development Center Americas; Takeda Oncology

Most Recent Events

  • 23 Aug 2023 Time frame of primary endpoint has been changed from randomization until PD or death (up to 52 months).
  • 01 Jul 2023 Results of a sub-group analysis assessing safety and efficacy sub-grouped by age and frailty status published in the Clinical Lymphoma, Myeloma & Leukemia
  • 25 Apr 2023 Results of exposure-response Analysis of the TOURMALINE-MM4 Study published in the Clinical Pharmacology and Therapeutics

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