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). On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

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