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

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2022-038
    NCT ID
    • NCT04973605
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Jeffrey
      Zonder, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Part 1: Dose Escalation

    Primary Objectives:

    • To evaluate the safety and tolerability of BGB-11417 in combination with dexamethasone and dexamethasone plus carfilzomib in patients with relapsed/refractory (R/R) multiple myeloma (MM) and t(11;14)
    • To determine the maximum tolerated dose/maximum assessed dose for BGB-11417 in combination with dexamethasone in patients with R/R MM and t(11;14)
    • To determine the recommended Phase 2 dose (RP2D) of BGB-11417 in combination with dexamethasone to be used in Part 2 (cohort expansion)
    • To determine the recommended dose for the combination of BGB-11417 plus dexamethasone plus carfilzomib to be used in Part 2

    Secondary Objective:

    • To assess the pharmacokinetics of BGB-11417 in combination with dexamethasone and with dexamethasone plus carfilzomib

    Exploratory Objectives:

    • To estimate the overall response rate of BGB-11417 in combination with dexamethasone and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14)
    • To assess the pharmacokinetics of dexamethasone in combination with BGB-11417

    Part 2: Cohort Expansion

    Primary Objectives:

    • To evaluate the safety and tolerability of BGB-11417 at the recommended Phase 2 dose as monotherapy and in combination with dexamethasone in patients with R/R MM and t(11;14)
    • To evaluate the safety and tolerability of BGB-11417 in combination with dexamethasone plus carfilzomib at the recommended dose for the combination therapy in patients with R/R MM and t(11;14)
    • To evaluate the efficacy of BGB-11417 as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14) as measured by overall response rate and additional response rates

    Secondary Objective:

    • To evaluate the efficacy of BGB-11417 as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib in patients with R/R MM and t(11;14) as measured by duration of response, time to response, and time-to-event outcomes

    Exploratory Objectives:

    • To explore the correlation between biomarker characteristics and efficacy outcomes
    • To evaluate the efficacy of BGB-11417 as measured by minimal residual disease
    • To explore the association between biomarker characteristics and resistance to BGB-11417
    • To further evaluate the pharmacokinetics of BGB-11417 when given as monotherapy, in combination with dexamethasone, and with dexamethasone plus carfilzomib
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266