42
Participants
Start Date
November 12, 2014
Primary Completion Date
March 31, 2019
Study Completion Date
June 4, 2020
MLN9708
"Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22 of a 28-day cycle.~Consolidation therapy~* Early consolidation (consolidation part 1) will comprise 2 cycles of MRD identical to induction therapy.~* Late consolidation (consolidation part 2) will consist in 6 additional cycles of MLN9708 (4 mg on Days 1, 8 and 15) plus lenalidomide (25 mg on Days 1 through 21) of a 28-day cycle.~Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months."
Lenalidomide
Dexamethasone
CHRU Dijon, Dijon
Pole IUC Oncopole CHU, Toulouse
CHRU - Hôpital du Haut Lévêque, Bordeaux
CHRU - Hôpital Bretonneau, Tours
Nantes University Hospital, Nantes
CHRU - Hôpitaux de Brabois, Vandœuvre-lès-Nancy
CHRU - Hôpital Claude Huriez, Lille
Centre Hospitalier Lyon sud, Pierre-Bénite
Centre hospitalier départemental Vendée, La Roche-sur-Yon
Hôpital Saint-Antoine, Paris
Nantes University Hospital
OTHER