A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

Phase 3

Recruiting

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Drug: Carfilzomib; Drug: Mezigdomide; Drug: Dexamethasone

• Registration Number: NCT05552976
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2023-01-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-01
• Primary Completion: 2026-02-04
• Study Completion: 2029-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)	Dexamethasone	-
Kd (Carfilzomib + Dexamethasone)	Carfilzomib	-
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)	Mezigdomide	-
Kd (Carfilzomib + Dexamethasone)	Dexamethasone	-
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)	Carfilzomib	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to approximately 5 years

Secondary Outcome Measures

Name	Time	Method
Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)	Up to approximately 5 years	VGPRR will be calculated as the percentage of participants who achieve best response of VGPR or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.
Time To Response (TTR)	Up to approximately 5 years
Progression-free Survival 2 (PFS-2)	Up to approximately 5 years
Number Of Participants With Adverse Events (AEs)	Up to approximately 5 years
Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	Up to approximately 5 years	The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only.
Recommended Mezigdomide Dose	Up to 12 months	Stage 1 only
Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone	Up to 176 days	Stage 1 only
Overall Survival (OS)	Up to approximately 5 years
Overall Response (OR)	Up to approximately 5 years
Complete Response (CR) Or Better (CRR)	Up to approximately 5 years	CRR will be calculated as the percentage of participants who achieve best response of CR or better according to the IMWG Uniform Response Criteria for Multiple Myeloma.
Duration Of Response (DOR)	Up to approximately 5 years
Time To Progression (TTP)	Up to approximately 5 years
Time To Next Treatment (TTNT)	Up to approximately 5 years
Minimal Residual Disease (MRD) Negativity Rate	Up to approximately 5 years
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	Up to approximately 5 years	The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only.

Trial Locations

Locations (217)

Local Institution - 0046; 🇺🇸 Mobile, Alabama, United States

Local Institution - 0005; 🇺🇸 Cerritos, California, United States

Local Institution - 0190; 🇺🇸 Irvine, California, United States

Local Institution - 0187; 🇺🇸 Los Angeles, California, United States

Local Institution - 0344; 🇺🇸 Santa Rosa, California, United States

Local Institution - 0339; 🇺🇸 Stockton, California, United States

Local Institution - 0279; 🇺🇸 Newark, Delaware, United States

Local Institution - 0341; 🇺🇸 Fort Myers, Florida, United States

Local Institution - 0342; 🇺🇸 Saint Petersburg, Florida, United States

Local Institution - 0340; 🇺🇸 West Palm Beach, Florida, United States

Scroll for more (207 remaining)