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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05558319 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
PETHEMA Foundation |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Juan José Lahuerta Palacios, DrJoan Bladé, DrMª Victoria Mateos, DrEnrique M Ocio, DrJesús San Miguel, Dr |
Principal Investigator Affiliation | Hospital Universitario 12 de OctubreHospital Clinic of BarcelonaHospital Clínico Universitario de SalamancaHospital Universitario Marqués de ValdecillaClínica Universitaria de Navarra |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Not yet recruiting |
Countries | Spain |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Newly Diagnosed Multiple Myeloma |
Patients will receive induction treatment, which will consist: arm A (Isatuximab-VRD + ASCT) or arm B (VRD extended + ASCT plus ERI) or arm C (Isatuximab-VID + ASCT). After ASTC, patients will start consolidation which will be 2 cycles of similar treatment to induction. Continuous treatment will follow after consolidation and patients will receive:
Active Comparator: Control arm (A)
INDUCTION: Isatuximab + VRD, 4 cycles. Isatuximab (IV) 10 mg/Kg, 1st cycle D: 1,8,15, 22. Cycles 2-4: D 1,15. Bortezomib (SC) 1.3 mg/m2, D:1, 4, 8, 11. Lenalidomide (PO) 25mg, D:1-21. Dexamethasone (PO) 40 mg, D: 1-4, 9-12. ASCT. The conditioning regimen is melphalan 200 mg/m2. CONSOLIDATION: Isatuximab + VRD, 2 cycles. Isatuximab (IV) 10 mg/Kg. D 1-15. Bortezomib (SC) 1.3 mg/m2, D:1, 4, 8, 11. Lenalidomide (PO) 25mg, D:1-21. Dexamethasone (PO) 40 mg, D: 1-4, 9-12. CONTINUOUS TREATMENT: Lenalidomide and monthly Isatuximab until progression, unacceptable toxicity, patient withdrawal, loss to follow up or death. During continuous treatment, dexamethasone 40 mg is used as a standardized premedication for Isatuximab.
Experimental: EXPERIMENTAL ARM (B): Extended VRD and Early Rescue Intervention
INDUCTION: Includes two experimental lines: VRD extended to 18 cycles: Induction (VRDx6): Bortezomib (SC) 1.3 mg/m2, D: 1, 4, 8, and 11 (Q4W). Lenalidomide 25 mg (PO), D: 1-21 (Q4W). Dexamethasone 40 mg (PO) D 1 to 4 and 9 to 12 (Q4W). Isatuximab (IV) 10 mg/kg, D: 1, 8, 15, and 22 (Q4W) and D: 1-15 in subsequent cycles. Early detection of treatment failure and Early Rescue Intervention (ERI): Isatuximab-Iberdomide-Dexamethasone in continuous treatment. Isatuximab (IV) 10mg/kg Cycle 1: Days 1, 8, 15, and 22 (Q4W). Cycles 2 onwards: Days 1 and 15 (Q4W). Isatuximab will be infused monthly after 1 year treatment (Day 1 Q4W) including ASCT. Iberdomide (PO) 1,6 mg. D: 1-21 (Q4W). Dexamethasone (PO) 40 mg. D: 1, 8, 15, and 22 (Q4W). ASCT. The conditioning regimen is melphalan 200 mg/m2. CONSOLIDATION (VRDx2)- Extended VRD: VDx10, followed by lenalidomide plus dexamethasone maintenance. CONTINUOUS TREATMENT: Lenalidomide 15 mg, D: 1-21, and dexamethasone 20 mg, D: 1-4 (Q4W).
Experimental: EXPLORATORY ARM (C)
INDUCTION: Iberdomide plus Isatuximab, bortezomib and dexamethasone (four cycles). Isatuximab (IV) 10 mg/kg D 1, 8, 15, and 22 in the first Q4W; and days 1-15 in subsequent cycles. Iberdomide (PO) at 1.6 mg on days 1-21 of every 4-week cycle. Bortezomib (SC) at 1.3 mg/m2 on days 1, 4, 8, and 11 of every 4-week cycle. Dexamethasone 40 mg (PO) D 1-4, 9-12 (Q4W). ASCT. The conditioning regimen is melphalan 200 mg/m2. CONSOLIDATION: two cycles (Q4W) of Isatuximab, Iberdomide, Bortezomib and Dexamethasone, as in induction, starting approximately 2 months after hospital discharge or 3 months after transplantation. Isatuximab will be infused monthly since the start of continuous therapy (after the second cycle of consolidation). CONTINUOUS TREATMENT: Iberdomide and monthly Isatuximab until progression, unacceptable toxicity, patient withdrawal, loss to follow up or death. During continuous treatment, dexamethasone 40 mg is used as a standardized premedication for Isatuximab.
Drug: - Bortezomib
Bortezomib
Drug: - Isatuximab
Isatuximab
Drug: - Iberdomide
Iberdomide
Drug: - Lenalidomide
Lenalidomide
Drug: - Dexamethasone
Dexamethasone
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Address
Hospital Principe de Asturias
Alcalá de Henares, Madrid,
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Hospital Universitario Quirón Salud Madrid
Pozuelo De Alarcón, Madrid, 28223
Site Contact
Carmen Martínez Chamorro
carmenmartinezchamorro@quironsalud.es ; carmenmartinezchanomorro@hotmail.com
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Clinica Universidad Navarra (CUN)
Pamplona, Navarra, 31008
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Hospital General Universitario de Albacete
Albacete, ,
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Hospital Germans Trias i Pujol (ICO BADALONA)
Badalona, ,
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Hospital Clinic i Provincial de Barcelona
Barcelona, ,
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Hospital de la Santa Creu i Sant Pau
Barcelona, ,
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Hospital Universitari Vall d´Hebron
Barcelona, ,
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ICO L´Hospitalet
Barcelona, ,
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Hospital Universitario de Cruces
Bilbao, ,
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Hospital Universitario de Burgos
Burgos, , 09006
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Complejo Hospitalario de Cáceres
Cáceres, ,
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Hospital Universitario de Cabueñes
Gijón, ,
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Hospital Universitari Dr. Josep Trueta (ICO Girona)
Girona, ,
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Hospital Universitario Virgen de las Nieves
Granada, ,
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Hospital Universitario de Guadalajara
Guadalajara, ,
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H.Universitario de Jerez de la Frontera
Jerez De La Frontera, ,
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Hospital Universitario de Canarias
La Laguna, ,
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Complejo Asistencial Universitario de León
León, ,
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Hospital Arnau de Vilanova (Lleida)
Lleida, ,
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Hospital San Pedro
Logroño, ,
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Complejo Hospitalario Lucus Augusti
Lugo, ,
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Fundación Jiménez Díaz-Ute
Madrid, ,
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Hospital General Universitario Gregorio Marañón
Madrid, ,
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Hospital HLA Universitario Moncloa
Madrid, ,
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Hospital Universitario 12 de octubre
Madrid, ,
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Hospital Universitario Clínico San Carlos
Madrid, ,
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Hospital Universitario de Fuenlabrada
Madrid, ,
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Hospital Universitario de la Princesa
Madrid, ,
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Hospital Universitario Fundación Alcorcón
Madrid, ,
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Hospital Universitario HM Sanchinarro
Madrid, ,
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Hospital Universitario Infanta Leonor
Madrid, ,
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Hospital Universitario La Paz
Madrid, ,
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Hospital Universitario La Zarzuela
Madrid, ,
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Hospital Universitario Puerta del Hierro
Madrid, ,
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Hospital Universitario Ramón y Cajal
Madrid, ,
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H. Morales Meseguer
Murcia, ,
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H. Un. Virgen de la Arrixaca
Murcia, ,
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Hospital General Universitario Santa Lucía
Murcia, ,
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Hospital Costa del Sol
Málaga, ,
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Hospital Regional de Málaga
Málaga, ,
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Hospital U Niversitario Virgen de La Victoria
Málaga, ,
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Hospital Universitario Rey Juan Carlos
Móstoles, ,
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Complejo Hospitalario Universitario de Ourense
Ourense, ,
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Hospital Universitario Central de Asturias
Oviedo, ,
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Hospital Son Llatzer
Palma De Mallorca, ,
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Hospital Universitari Son Espases
Palma De Mallorca, ,
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Complejo Hospitalario de Navarra
Pamplona, ,
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Complejo Hospitalario de Pontevedra
Pontevedra, ,
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Hospital Clinico Universitario Salamanca
Salamanca, , 37007
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Hospital Universitario Infanta Sofía
San Sebastián De Los Reyes, ,
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Hospital Universitario de Donostia
San Sebastián, ,
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Complejo Hospitalario Universitario Nuestra Señora de la Candelaria
Santa Cruz De Tenerife, ,
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H. Universitario Marqués de Valdecilla
Santander, ,
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Complejo Hospitalario Santiago (CHUS)
Santiago De Compostela, ,
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Hospital General de Segovia
Segovia, ,
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Complejo Hospitalario Regional Virgen Del Rocío
Sevilla, ,
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H. Universitario de Valme
Sevilla, ,
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Hospital Universitario Reina Sofía
Sevilla, ,
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Hospital Universitari de Tarragona Joan XXIII
Tarragona, ,
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Hospital Universitari Mutua Terrassa
Terrassa, ,
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Complejo Hospitalario de Toledo (Virgen de la Salud)
Toledo, ,
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Hospital Clínico Universitario de Valencia
Valencia, ,
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Hospital Universitari i Politecnic la Fe
Valencia, ,
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Hospital Universitario Dr. Peset Aleixandre
Valencia, ,
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H. U. Txagorritxu
Vitoria, ,
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Hospital Clinico Universitario Lozano Blesa
Zaragoza, ,
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Hospital Universitario Miguel Servet
Zaragoza, ,