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Clinical Trials List

Protocol NumberCA057-008
NCT Number(ClinicalTrials.gov Identfier)NCT05552976
Active

2022-09-01 - 2026-12-31

Phase III

Recruiting7

ICD-10E04.0

Nontoxic diffuse goiter

ICD-9240.0

Goiter, specified as simple

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

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Jen Liu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 滕傑林 Division of General Internal Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳志丞 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馬銘君 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 裴松南 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 裴松南 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Relapsed or Refractory Multiple Myeloma

Objectives

To compare progression-free survival (PFS) between CC-92480, carfilzomib, and dexamethasone (480Kd) and carfilzomib and dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma (RRMM)

Test Drug

CC-92480 (BMS-986348)

Active Ingredient

CC-92480 (BMS-986348)

Dosage Form

Capsule

Dosage

0.2 mg、0.3 mg、0.4 mg、0.6 mg、0.8 mg、1.0 mg

Endpoints

‧ PFS: The time from randomization until the first confirmed progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma or death from any cause, whichever occurs first

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    525 participants

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