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 3Active Not RecruitingNCT05552976

Bristol-Myers Squibb525 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

525

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

MezigdomideDRUG

Specified dose on specified days

CarfilzomibDRUG

Specified dose on specified days

DexamethasoneDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria \- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or. ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,. iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels \> 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio. * Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, \[with or without\] hematopoietic stem cell transplant, (with or without) consolidation, and/or \[with or without\] maintenance therapy). * Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received \< 2 cycles are still eligible). * Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy. * Participant must have documented disease progression during or after their last antimyeloma regimen. Exclusion Criteria * Participant who has had prior treatment with mezigdomide or carfilzomib. * Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (207)

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

Time frame: Up to approximately 5 years

Secondary Outcomes

Recommended Mezigdomide Dose

Stage 1 only

Time frame: Up to 12 months

Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone

Stage 1 only

Time frame: Up to 176 days

Overall Survival (OS)

Time frame: Up to approximately 5 years

Overall Response (OR)

Time frame: Up to approximately 5 years

Rate Of Very Good Partial Response (VGPR) Or Better (VGPRR)

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 frame: Up to approximately 5 years

Complete Response (CR) Or Better (CRR)

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.

Time frame: Up to approximately 5 years

Time To Response (TTR)

Time frame: Up to approximately 5 years

Duration Of Response (DOR)

Time frame: Up to approximately 5 years

Data from ClinicalTrials.gov

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Local Institution - 0046

Mobile, Alabama, United States

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Cerritos, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Santa Rosa, California, United States

Local Institution - 0339

Stockton, California, United States

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Newark, Delaware, United States

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Fort Myers, Florida, United States

Local Institution - 0342

St. Petersburg, Florida, United States

Local Institution - 0340

West Palm Beach, Florida, United States

...and 197 more locations

Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)

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.

Time frame: Up to approximately 5 years