Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Titre officiel

DREAMM 7: A Multicentre, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma

Sommaire:

Il s’agit d’une étude ouverte de phase 3 à répartition aléatoire visant à évaluer l’innocuité et l’efficacité du belantamab mafodotine en association avec le bortézomib/la dexaméthasone (groupe A) par rapport au daratumumab en association avec le bortézomib/la dexaméthasone (groupe B) chez les participants atteints d’un myélome multiple récidivant réfractaire.

Description de l'essai

Primary Outcome:

  • Progression-free survival
Secondary Outcome:
  • Complete response rate (CRR)
  • Overall response rate (ORR)
  • Duration of response (DoR) after administration of study treatment
  • Time to response (TTR) after administration of study treatment
  • Time to Progression (TTP) after administration of study treatment
  • Overall survival (OS)
  • Progression-free survival on subsequent line of therapy (PFS2)
  • Minimal Residual Disease (MRD) negativity rate after administration of study treatment
  • Number of participants with adverse events (AEs)
  • Number of participants with serious adverse events (SAEs)
  • Number of participants with abnormal ocular findings on ophthalmic examination
  • Plasma concentrations of belantamab mafodotin at indicated time points
  • Plasma concentrations of total monoclonal antibody (mAb) at indicated time points
  • Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
  • Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
  • Titers of ADAs against belantamab mafodotin
  • Change from Baseline in symptoms as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
  • Change from Baseline in impacts as measured by PRO-CTCAE
  • Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)
  • Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20)
Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study, whichever occurs first.

Voir cet essai sur ClinicalTrials.gov

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