A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib in Multiple Myeloma

Official Title

A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone and Carfilzomib/Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)

Summary:

Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in combination with dexamethasone and carfilzomib intravenously across two cohorts with a monotherapy component as well.

Trial Description

Primary Outcome:

  • Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
  • Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5
  • Part 2: Overall response rate (ORR)
  • Part 2: Very good partial response (VGPR) or better response rate
  • Part 2: Complete Response (CR) or better
Secondary Outcome:
  • Part 1: Area under the plasma concentration-time curve (AUC)
  • Part 1: Maximum observed plasma concentration (Cmax)
  • Part 1: Time to reach Cmax (tmax)
  • Part 1: After steady-state: AUC last,ss
  • Part 1: After steady-state: Cmax, ss
  • Part 1: After steady-state: trough plasma concentration (Ctrough) ss
  • Part 1: After steady-state: time to reach Cmax (tmax,ss)
  • Part 2: Time to response (TTR) as assessed by investigator
  • Part 2: Duration of response (DOR) as assessed by investigator
  • Part 2: Progression-free survival (PFS) as assessed by investigator
  • Part 2: Overall survival (OS) as assessed by investigator

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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