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NCT Number: NCT05552976

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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mezigdomide

Drug

Specified dose on specified days

Other names: BMS-986348, CC-92480

Carfilzomib

Drug

Specified dose on specified days

Other names: Kyprolis

Dexamethasone

Drug

Specified dose on specified days

Other names: Decadron, Dex

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Recommended Mezigdomide Dose

    Time frame: Up to 12 months

    Stage 1 only

  2. Plasma concentrations of Mezigdomide in Combination with Carfilzomib and Dexamethasone

    Time frame: Up to 176 days

    Stage 1 only

  3. Overall Survival (OS)

    Time frame: Up to approximately 5 years

  4. Overall Response (OR)

    Time frame: Up to approximately 5 years

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

    Time frame: 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.

  6. Complete Response (CR) Or Better (CRR)

    Time frame: 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.

  7. Time To Response (TTR)

    Time frame: Up to approximately 5 years

  8. Duration Of Response (DOR)

    Time frame: Up to approximately 5 years

  9. Time To Progression (TTP)

    Time frame: Up to approximately 5 years

  10. Time To Next Treatment (TTNT)

    Time frame: Up to approximately 5 years

  11. Progression-free Survival 2 (PFS-2)

    Time frame: Up to approximately 5 years

  12. Minimal Residual Disease (MRD) Negativity Rate

    Time frame: Up to approximately 5 years

  13. Number Of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 5 years

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

    Time frame: 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.

  15. Change From Baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2

Acronym: SUCCESSOR-2

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Sep 23, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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