142
Participants
Start Date
May 16, 2017
Primary Completion Date
January 11, 2024
Study Completion Date
December 31, 2024
Ixazomib
Ixazomib capsules. Phase I: Starting dose of Ixazomib: 3.0 or 4.0 mg by day +1, +8 and +15. Phase II: Starting Dose of Ixazomib: Maximum tolerated dose from Phase I.
Tacrolimus
Tacrolimus at dose of 0.02 mg/kg/day and then 0.06 mg/kg/day.
Sirolimus
Sirolimus oral solution. Standing 6 mg orally on day -5 and continued 4mg per day. This drugs should be slowly tapered starting 3 months posttransplant in order to stop them at 9 to 12 months posttransplant according to physician criteria.
Any prophylaxis for GVHD
Except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.
Hospital Universitario Ramón y Cajal, Madrid
Hospital Universitario Virgen del Rocío, Seville
ICO- Hospital Germans Trias i Pujol, Badalona
Hospital Clinic de Barcelona, Barcelona
Hospital de la Santa Creu I Sant Pau, Barcelona
Hospital Universitario Vall D´Hebrón, Barcelona
Hospital Clinico Universitario Salamanca, Salamanca
Hospital Clínico Universitario de Valencia, Valencia
Spanish Clinical Research Network - SCReN
NETWORK
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER