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)

Summary:

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.

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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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society