Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

January 11, 2024

Study Completion Date

December 31, 2024

Conditions
Hematopoietic Stem Cell TransplantationMultiple Myeloma
Interventions
DRUG

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.

DRUG

Tacrolimus

Tacrolimus at dose of 0.02 mg/kg/day and then 0.06 mg/kg/day.

DRUG

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.

DRUG

Any prophylaxis for GVHD

Except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.

Trial Locations (8)

28034

Hospital Universitario Ramón y Cajal, Madrid

41013

Hospital Universitario Virgen del Rocío, Seville

Unknown

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

All Listed Sponsors
collaborator

Spanish Clinical Research Network - SCReN

NETWORK

lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER