RecruitingPhase 3NCT05558319

NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide

GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D

Sponsor

PETHEMA Foundation

Enrollment

480 participants

Start Date

Nov 10, 2022

Study Type

INTERVENTIONAL

Conditions

Newly Diagnosed Multiple Myeloma

Summary

This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms. Patients will receive VRD extended + ASCT plus ERI or Isatuximab-VRD + ASCT or Isatuximab-VID + ASCT.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bortezomib, a drug called Dexamethasone, and others for people with newly diagnosed multiple myeloma. The study is currently recruiting participants at 68 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBortezomib

Bortezomib

DRUGIsatuximab

Isatuximab

DRUGIberdomide

Iberdomide

DRUGLenalidomide

Lenalidomide

DRUGDexamethasone

Dexamethasone

Locations(68)

Hospital Principe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Universitario Quirón Salud Madrid

Pozuelo de Alarcón, Madrid, Spain

Clinica Universidad Navarra (CUN)

Pamplona, Navarre, Spain

Hospital General Universitario de Albacete

Albacete, Spain

Hospital Germans Trias i Pujol (ICO BADALONA)

Badalona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d´Hebron

Barcelona, Spain

ICO L´Hospitalet

Barcelona, Spain

Hospital Universitario de Cruces

Bilbao, Spain

Hospital Universitario de Burgos

Burgos, Spain

Complejo Hospitalario de Cáceres

Cáceres, Spain

Hospital Universitario de Cabueñes

Gijón, Spain

Hospital Universitari Dr. Josep Trueta (ICO Girona)

Girona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario de Guadalajara

Guadalajara, Spain

H.Universitario de Jerez de la Frontera

Jerez de la Frontera, Spain

Complejo Asistencial Universitario de León

León, Spain

Hospital Arnau de Vilanova (Lleida)

Lleida, Spain

Hospital San Pedro

Logroño, Spain

Complejo Hospitalario Lucus Augusti

Lugo, Spain

Fundación Jiménez Díaz-Ute

Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital HLA Universitario Moncloa

Madrid, Spain

Hospital Universitario 12 de octubre

Madrid, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hospital Universitario de Fuenlabrada

Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital Universitario Fundación Alcorcón

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario La Zarzuela

Madrid, Spain

Hospital Universitario Puerta del Hierro

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Costa del Sol

Málaga, Spain

Hospital Regional de Málaga

Málaga, Spain

Hospital U Niversitario Virgen de La Victoria

Málaga, Spain

Hospital Universitario Rey Juan Carlos

Móstoles, Spain

H. Morales Meseguer

Murcia, Spain

H. Un. Virgen de la Arrixaca

Murcia, Spain

Hospital General Universitario Santa Lucía

Murcia, Spain

Complejo Hospitalario Universitario de Ourense

Ourense, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Son Llatzer

Palma de Mallorca, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Complejo Hospitalario de Navarra

Pamplona, Spain

Complejo Hospitalario de Pontevedra

Pontevedra, Spain

Hospital Clinico Universitario Salamanca

Salamanca, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Hospital Universitario de Donostia

San Sebastián, Spain

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Spain

Complejo Hospitalario Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain

H. Universitario Marqués de Valdecilla

Santander, Spain

Complejo Hospitalario Santiago (CHUS)

Santiago de Compostela, Spain

Hospital General de Segovia

Segovia, Spain

Complejo Hospitalario Regional Virgen Del Rocío

Seville, Spain

H. Universitario de Valme

Seville, Spain

Hospital Universitario Reina Sofía

Seville, Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Hospital Universitari Mutua Terrassa

Terrassa, Spain

Complejo Hospitalario de Toledo (Virgen de la Salud)

Toledo, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politecnic la Fe

Valencia, Spain

Hospital Universitario Dr. Peset Aleixandre

Valencia, Spain

H. U. Txagorritxu

Vitoria-Gasteiz, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

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NCT05558319

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