50
Participants
Start Date
April 7, 2021
Primary Completion Date
March 31, 2025
Study Completion Date
July 31, 2025
Belantamab mafodotin
"Dose of 2.5 mg/kg/every 8 weeks on day 1, intravenously, Induction: three induction cycles with belantamab mafodotin in combination with VRd.~Consolidation: one cycle after 90 days of transplantation with belantamab mafodotin in combination with VRd.~Maintenance: belantamab mafodotin in combination with lenalidomide until disease progression, patients withdrawal, death or up to two years, whichever occurs first"
Bortezomib
Dose of 1.3 mg/m2, on days: 1, 4, 8 and 11 of every 28-day cycle. Subcutaneous administration Induction: 6 cycles Consolidation: 2 cycles
Lenalidomide
Dose of 25 mg/day on days 1-21 of every 28-day cycle. Oral administration. Induction: 6 cycles Consolidation: 2 cycles Maintenance: 10 mg/day on days 1-21 continuously (may increase up to 15 mg/day) until disease progression, patients withdrawal, death, whichever occurs first
Dexamethasone
Dose of 20 mg on days: 1, 2, 4, 5, 8, 9, 11 and 12 of every 28-day cycle. Oral administration Induction: 6 cycles Consolidation: 2 cycles
Autologous stem cell transplant (ASCT)
High-dose melphalan (200 mg/m2) and ASCT will be performed as per routine practice
RECRUITING
Complejo Universitario Hospitalario de Santiago, Santiago de Compostela
RECRUITING
Hospital Gregorio Marañon, Madrid
RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Hospital General Universitario Morales Meseguer, Murcia
WITHDRAWN
Clinica Universidad Navarra (CUN), Pamplona
RECRUITING
Hospital de Cabueñes, Gijón
RECRUITING
Hospital Universitario de Salamanca, Salamanca
NOT_YET_RECRUITING
Hospital Universitario de Canarias, San Cristóbal de La Laguna
RECRUITING
Hospital Universitario Marqués de Valdecilla, Santander
WITHDRAWN
Complejo Hospitalario Regional Virgen del Rocío, Seville
RECRUITING
Hospital Universitario y Policlínico de la Fe, Valencia
RECRUITING
Hospital Son Llatzer, Palma de Mallorca
WITHDRAWN
Institut Catala d'Oncologia (ICO) Badalona, Badalona
NOT_YET_RECRUITING
Hospital Clínic I Provincial de Barcelona, Barcelona
WITHDRAWN
Institut Catala d'Oncologia (ICO) Hospitalet, L'Hospitalet de Llobregat
RECRUITING
Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria
RECRUITING
Hospital Infanta Leonor, Madrid
RECRUITING
Hospital Virgen de la Arrixaca, Murcia
Collaborators (1)
GlaxoSmithKline
INDUSTRY
PETHEMA Foundation
OTHER