A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma

Official Title

A Phase 2, Multicentre, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Summary:

This is an open-label, multicentre study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3).

Trial Description

Primary Outcome:

  • Overall Response Rate (ORR)
  • Adverse Events (AEs)
Secondary Outcome:
  • Time to response (TTR)
  • Duration of Response (DOR)
  • Progression-free Survival (PFS)
  • Pharmacokinetics- Cmax
  • Pharmacokinetics- AUC
  • Pharmacokinetics- Tmax
  • Pharmacokinetics- t1/2
  • Pharmacokinetics- CL/F
  • Pharmacokinetics- Vz/F

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society