Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

Official Title

(INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Summary:

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Trial Description

Primary Outcome:

  • Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone
  • Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment
  • Incidence of treatment-emergent adverse events
  • Number of patients with changes in laboratory test results
Secondary Outcome:
  • Maximum observed concentration (Cmax)
  • Time to Cmax (tmax)
  • Area under the concentration-time curve
  • Overall response
  • Best overall response
  • Progression free survival
  • Duration of response
A multicentre, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.

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