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A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

Trial Profile

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2019

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At a glance

  • Drugs Daratumumab (Primary) ; Dexamethasone; Dexamethasone; Lenalidomide
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms MAIA
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 30 Oct 2019 According to a Janssen Pharmaceuticals media release, the Health Canada recently approved under Priority Review DARZALEX daratumumab), in combination with lenalidomide and dexamethasone (Rd), for newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from this phase III (MAIA) study.
    • 18 Oct 2019 According to a Genmab media release, final decision from European Commission expected in the coming months.
    • 18 Oct 2019 According to a Genmab media release, the CHMP of the EMA has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX (daratumumab) in the European Union. The recommendation is for the use of DARZALEX in combination with lenalidomide and dexamethasone (Rd) as treatment for newly diagnosed adult patients with multiple myeloma who are ineligible for autologous stem cell transplant. This opinion based on data from this Phase III (MAIA) study.
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