A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).

Official Title
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A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: BMS-986393
* Drug: Alnuctamab
* Drug: Mezigdomide
* Drug: Iberdomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2) Measurable multiple myeloma (MM) Eastern Cooperative Oncology Group performance status of 0-1 Exclusion Criteria: Condition that confounds the ability to interpret data from the study Known active or history of central nervous system (CNS) involvement of MM Note: Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: BMS-986393 + Alnuctamab<br> | Drug: BMS-986393<br>* Specified dose on specified days<br>* Other names: CC-95266;Drug: Alnuctamab<br>* Specified dose on specified days<br>* Other names: EM901;|
| Experimental: Arm B: BMS-986393 + Mezigdomide<br> | Drug: BMS-986393<br>* Specified dose on specified days<br>* Other names: CC-95266;Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;|
| Experimental: Arm C: BMS-986393 + Iberdomide<br> | Drug: BMS-986393<br>* Specified dose on specified days<br>* Other names: CC-95266;Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: CC-220;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to 2 years | 
| Incidence of serious adverse events (SAEs) |  | Up to 2 years | 
| Incidence of adverse events of special interest (AESI) |  | Up to 2 years | 
| Incidence of AEs leading to discontinuation |  | Up to 2 years | 
| Number of Deaths |  | Up to 2 years | 
| Establish recommended Phase 2 dose (RP2D) |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) |  | Up to 2 years | 
| Complete response rate (CRR) |  | Up to 2 years | 
| Very good partial response rate (VGPRR) |  | Up to 2 years | 
| Maximum observed concentration (Cmax) |  | Up to 2 years | 
| Time of maximum observed concentration (tmax) |  | Up to 2 years | 
| Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986393, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, First-in-human, Alnuctamab, Mezigdomide, Iberdomide, CC-95266, GPRC5D, GPRC5D CAR T, Cell Therapy, CAR T cell therapy, Combination therapy