Estudio de fase 3, de dos etapas, aleatorizado, multicéntrico, abierto que compara mezigdomida (CC-92480/BMS-986348), carfilzomib y dexametasona (MeziKD) frente a carfilzomib y dexametasona (Kd) en participantes con mieloma múltiple en recaída o refractario (MMRR): SUCCESSOR-2

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05552976Tipo: INTERVENTIONALInicio: 10 de ene de 2023Fin estimado: 25 de jul de 2029

Resumen

El objetivo del estudio es comparar mezigdomida (CC-92480/BMS-986348) con carfilzomib y dexametasona (MeziKD) frente a carfilzomib y dexametasona (Kd) en el tratamiento del MMRR: SUCCESSOR-2.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\- 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.

Criterios de exclusión

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.

Intervenciones

drug

Mezigdomide

Specified dose on specified days

drug

Carfilzomib

Specified dose on specified days

drug

Dexamethasone

Specified dose on specified days

Ubicaciones

Local Institution - 0008

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0079

ABB, Buenos Aires F.D., Argentina

Local Institution - 0182

Rosario, Santa Fe Province, Argentina

Local Institution - 0319

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0150

Buenos Aires, Argentina

Local Institution - 0151

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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