Trial intelligence / Profile preview

MyDRUG: Genomic-Guided Targeted Therapy in Relapsed Multiple Myeloma

NCT03732703Phase 2

Key facts

Status
Completed
Start
Apr 2019
Primary completion
Dec 2024
Countries
1
Modality
Monoclonal Antibodies, Recombinant Proteins and Enzymes, Antibody-Drug Conjugates (ADCs)
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, randomised, open-label trial of abemaciclib, enasidenib, cobimetinib, erdafitinib, venetoclax and 3 more in multiple myeloma (MM) (8 arms). Primary endpoints: Overall Response Rate - Actionable Genetic Alteration at 2 years and Overall Response Rate - Non-Actionable Genetic Alteration at 2 years. Started Apr 2019; status: completed.

02

Design

8 arms
Study design
RandomizedOpen-label
  • Abemaciclib + IPd

    Abemaciclib + Ixazomib/Pomalidomide/Dexamethasone for CDKN2C alteration

  • Enasidenib + IPd

    Enasidenib + Ixazomib/Pomalidomide/Dexamethasone for IDH2 mutation

  • Cobimetinib + IPd

    Cobimetinib + Ixazomib/Pomalidomide/Dexamethasone for RAF/RAS mutation

  • Erdafitinib + IPd

    Erdafitinib + Ixazomib/Pomalidomide/Dexamethasone for FGFR3 mutation

  • Venetoclax + IPd (Randomized)

    Venetoclax + Ixazomib/Pomalidomide/Dexamethasone vs IPd Control for t(11;14)

  • Daratumumab + IPd

    Daratumumab + Ixazomib/Pomalidomide/Dexamethasone for Non-Actionable

2 more in the full profile.

03

Who it enrols

Patients with relapsed/refractory multiple myeloma who have received 1-3 prior lines of therapy (including a PI and IMiD) and have specific genomic mutations (CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2, t(11;14)) or no actionable mutations.

04

Endpoints

Primary

  • Overall Response Rate - Actionable Genetic Alteration

  • Overall Response Rate - Non-Actionable Genetic Alteration

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