An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants with Relapsed or Refractory Multiple Myeloma

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Brief summary

Safety : Type, frequency, seriousness, and severity of adverse events (AEs), and relationship of AEs to study treatment., Recommended Phase 2 Dose (RP2D): Establish the RP2D for CC-92480 in each novel treatment combination with dexamethasone.

Detailed description

Overall Response Rate (ORR) : Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria89, Complete Response Rate (CRR): Percentage of participants who achieved ≥ complete response (CR), according to IMWG Uniform Response Criteria, Very Good Partial Response Rate (VGPRR) : Percentage of participants who achieved ≥ VGPR, according to IMWG Response Criteria, Progression-Free Survival (PFS) : Time from enrollment to the first documentation of progressive disease (PD) or death from any cause during study, whichever occurs earlier, Time-to-Response (TTR) : Time from first dose to the first documentation of response (≥ PR), Duration of Response (DOR) : Time from the first documentation of response (≥ PR) to the first documentation of PD or death

Related papers

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Interventions

DRUGCC-92480

DRUGMekinist 2 mg film-coated tablets

DRUGDexamethason 4 mg JENAPHARM®

DRUGBET-Inhibitor

DRUGDexamethason 4 mg GALEN®

DRUGMekinist 0.5 mg film-coated tablets

DRUGTAZEMETOSTAT

DRUGDexamethason-ratiopharm® 4 mg Tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety : Type, frequency, seriousness, and severity of adverse events (AEs), and relationship of AEs to study treatment., Recommended Phase 2 Dose (RP2D): Establish the RP2D for CC-92480 in each novel treatment combination with dexamethasone.	—

Secondary

Measure	Time frame
Overall Response Rate (ORR) : Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria89, Complete Response Rate (CRR): Percentage of participants who achieved ≥ complete response (CR), according to IMWG Uniform Response Criteria, Very Good Partial Response Rate (VGPRR) : Percentage of participants who achieved ≥ VGPR, according to IMWG Response Criteria, Progression-Free Survival (PFS) : Time from enrollment to the first documentation of progressive disease (PD) or death from any cause during study, whichever occurs earlier, Time-to-Response (TTR) : Time from first dose to the first documentation of response (≥ PR), Duration of Response (DOR) : Time from the first documentation of response (≥ PR) to the first documentation of PD or death	—

Measure

Time frame

Overall Response Rate (ORR) : Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria89, Complete Response Rate (CRR): Percentage of participants who achieved ≥ complete response (CR), according to IMWG Uniform Response Criteria, Very Good Partial Response Rate (VGPRR) : Percentage of participants who achieved ≥ VGPR, according to IMWG Response Criteria, Progression-Free Survival (PFS) : Time from enrollment to the first documentation of progressive disease (PD) or death from any cause during study, whichever occurs earlier, Time-to-Response (TTR) : Time from first dose to the first documentation of response (≥ PR), Duration of Response (DOR) : Time from the first documentation of response (≥ PR) to the first documentation of PD or death

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Countries

Norway, Spain

Outcome results

None listed