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A Multi-ARM Phase Ib Study of SAR650984 (Isatuximab, an Anti-CD38 mAb) in Combination With Standard Carfilzomib, and High-dose Weekly Carfilzomib and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Trial Profile

A Multi-ARM Phase Ib Study of SAR650984 (Isatuximab, an Anti-CD38 mAb) in Combination With Standard Carfilzomib, and High-dose Weekly Carfilzomib and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2023

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At a glance

  • Drugs Carfilzomib (Primary) ; Isatuximab (Primary) ; Dexamethasone; Dexamethasone
  • Indications Multiple myeloma
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 14 May 2021 Planned number of patients changed from 118 to 89.
    • 18 Mar 2021 Results (n=33) assessing safety/tolerability, pharmacokinetics and preliminary efficacy of isatuximab in combination with carfilzomib in relapsed/refractory multiple myeloma, published in the Cancer
    • 26 Oct 2020 Protocol amended to remove Arm III (dexamethasone, isatuximab, carfilzomib, lenalidomide) from trial, Overall Response Rate (ORR) ARM II added to primary endpoint. Number of arms, number of planned patient number changed as reported by ClinicalTrial.gov record.
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