Estudio de fase 3, en dos etapas, aleatorizado, multicéntrico, abierto que compara mezigdomida (CC-92480), bortezomib y dexametasona (MEZIVd) versus pomalidomida, bortezomib y dexametasona (PVd) en sujetos con mieloma múltiple recidivante o refractario (MMRR): SUCCESSOR-1

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05519085Tipo: INTERVENTIONALInicio: 20 de sept de 2022Fin estimado: 30 de nov de 2033

Resumen

El propósito de este estudio es comparar la eficacia y la seguridad de mezigdomida (CC-92480), bortezomib y dexametasona (MeziVd) versus pomalidomida, bortezomib y dexametasona (PVd) en participantes con mieloma múltiple recidivante o refractario (MMRR) que recibieron entre 1 y 3 líneas previas de terapia y que tuvieron exposición previa a lenalidomida.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.
i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.
ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).
iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
Participants received 1 to 3 prior lines of antimyeloma therapy.
Participants achieved minimal response \[MR\] or better to at least 1 prior antimyeloma therapy.

Criterios de exclusión

\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.
i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.
ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.
For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
Participant has had prior treatment with mezigdomide or pomalidomide.

Intervenciones

drug

mezigdomide

Specified dose on specified days

drug

Pomalidomide

Specified dose on specified days

drug

Bortezomib

Specified dose on specified days

drug

Dexamethasone

Specified dose on specified days

Ubicaciones

Local Institution - 0318

Chivilcoy, Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Local Institution - 0213

Buenos Aires, Buenos Aires F.D., Argentina

ACTIVE_NOT_RECRUITING

Local Institution - 0249

Córdoba, Córdoba Province, Argentina

ACTIVE_NOT_RECRUITING

Local Institution - 0239

Viedma, R, Argentina

ACTIVE_NOT_RECRUITING

Local Institution - 0200

Rosario, Santa Fe Province, Argentina

ACTIVE_NOT_RECRUITING

Local Institution - 0248

S3000epv, Santa Fe Province, Argentina

COMPLETED

Local Institution - 0214

Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Patrocinadores

PrincipalCelgene

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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