A Study to Evaluate Alnuctamab in Combination With Mezigdomide 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 determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.

Official Title
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A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Alnuctamab
* Drug: Mezigdomide
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has a history of RRMM, and must: Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy. Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy. Exclusion Criteria: • Must not have previously received alnuctamab or mezigdomide. 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: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br> | Drug: Alnuctamab<br>* Specified dose on specified days<br>* Other names: EM901;Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Arm B1<br> | Drug: Alnuctamab<br>* Specified dose on specified days<br>* Other names: EM901;Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Arm B2<br> | Drug: Alnuctamab<br>* Specified dose on specified days<br>* Other names: EM901;Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Arm C1<br> | Drug: Alnuctamab<br>* Specified dose on specified days<br>* Other names: EM901;Drug: Mezigdomide<br>* Specified dose on specified days<br>* Other names: CC-92480;Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Arm C2<br> | Drug: Alnuctamab<br>* Specified dose on specified days<br>* Other names: EM901;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | 
| Number of participants with serious AEs (SAEs) |  | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | 
| Number of participants with AEs leading to discontinuation |  | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | 
| Number of deaths |  | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | 
| Number of participants with Dose-limiting toxicities (DLTs) |  | Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years) | 
| Overall Response Rate (ORR) | Phase 2 only | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response Rate (CRR) |  | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 
| Very Good Partial Response Rate (VGPRR) |  | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 
| Progression-free Survival (PFS) |  | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 
| Time-to-Response (TTR) |  | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 
| Duration of Response (DOR) |  | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 
| Overall Survival (OS) |  | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) | 
| ORR | Phase 1 only | From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years) |