A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Official Title

A Phase IB Multicentre, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)


This is a multicentre, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen. 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:

  • Dose-limiting Toxicities (DLTs)
Secondary Outcome:
  • Adverse Events (AEs)
  • Overall response rate (ORR)
  • Time to response (TTR)
  • Duration of response (DOR)
  • 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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Canadian Cancer Society

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