A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Official Title
-----------------
A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: CC-92480
* Drug: Bortezomib
* Drug: Dexamethasone
* Drug: Daratumumab
* Drug: Carfilzomib
* Drug: Elotuzumab
* Drug: Isatuximab
* Drug: Carfilzomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply: Documented diagnosis of multiple myeloma (MM) and measurable disease Documented disease progression during or after their last antimyeloma regimen Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen Exclusion Criteria: Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis Known central nervous system (CNS) involvement with myeloma Received immunosuppressive medication within the last 14 days of initiating study treatment Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Bortezomib<br>* Specified dose on specified days<br>Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Carfilzomib<br>* Specified dose on specified days<br>|
| Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Elotuzumab<br>* Specified dose on specified days<br>|
| Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Isatuximab<br>* Specified dose on specified days<br>|
| Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Bortezomib<br>* Specified dose on specified days<br>Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Carfilzomib<br>* Specified dose on specified days<br>|
| Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Elotuzumab<br>* Specified dose on specified days<br>|
| Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Isatuximab<br>* Specified dose on specified days<br>|
| Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Bortezomib<br>* Specified dose on specified days<br>Drug: Dexamethasone<br>* Specified dose on specified days<br>|
| Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Daratumumab<br>* Specified dose on specified days<br>|
| Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Daratumumab<br>* Specified dose on specified days<br>|
| Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Daratumumab<br>* Specified dose on specified days<br>|
| Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Daratumumab<br>* Specified dose on specified days<br>|
| Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Daratumumab<br>* Specified dose on specified days<br>|
| Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone<br> | Drug: CC-92480<br>* Specified dose on specified days<br>* Other names: mezigdomide;Drug: Dexamethasone<br>* Specified dose on specified days<br>Drug: Daratumumab<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended Dose |  | Up to approximately 3 years | 
| Recommended regimen as measured by dose-limiting toxicities |  | Up to approximately 3 years | 
| Number of participants with Adverse Events (AEs) |  | From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years | 
| Overall response rate (ORR) |  | Up to approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-response (TTR) |  | Up to approximately 5 years | 
| Duration of response (DOR) |  | Up to approximately 5 years | 
| Complete Response (CR) rate |  | Up to approximately 5 years | 
| Very good partial response (VGPR) rate - Cohorts D and E |  | Up to approximately 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newly Diagnosed Multiple Myeloma, Multiple Myeloma, CC-92480, Relapsed or Refractory Multiple Myeloma