A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05827016Tipo: INTERVENTIONALInicio: 22 de jun de 2023Fin estimado: 1 de ene de 2036

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Confirmed diagnosis of symptomatic multiple myeloma (MM).
Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) \[eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)\] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone \[D-VTd\] and daratumumab + bortezomib/ lenalidomide/dexamethasone \[D-VRd\]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone \[D-VCd\], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Criterios de exclusión

Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
Known central nervous system/meningeal involvement of MM.
Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.

Intervenciones

drug

Iberdomide

Specified dose on specified days

drug

Lenalidomide

Specified dose on specified days

Ubicaciones

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

Dorotea Fantl, Site 0183 · 005491151097180

RECRUITING

"Centro de Educación Médica e Investigaciones Clínicas ""Norberto Quirno"""

Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

Patricio Duarte, Site 0227 · 911052990100

RECRUITING

Local Institution - 0259

Mar del Plata, B, Argentina

WITHDRAWN

Hospital Universitario Austral

Pilar, B, Argentina

Mariano Berro, Site 0267 · +5491140799721

RECRUITING

Sanatorio Allende

Córdoba, Argentina

Gustavo Jarchum, Site 0182

RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

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

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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