Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

November 12, 2014

Primary Completion Date

March 31, 2019

Study Completion Date

June 4, 2020

Conditions
Newly Diagnosed Multiple Myeloma
Interventions
DRUG

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."

DRUG

Lenalidomide

DRUG

Dexamethasone

Trial Locations (10)

21000

CHRU Dijon, Dijon

31059

Pole IUC Oncopole CHU, Toulouse

33604

CHRU - Hôpital du Haut Lévêque, Bordeaux

37044

CHRU - Hôpital Bretonneau, Tours

44093

Nantes University Hospital, Nantes

54511

CHRU - Hôpitaux de Brabois, Vandœuvre-lès-Nancy

59037

CHRU - Hôpital Claude Huriez, Lille

69495

Centre Hospitalier Lyon sud, Pierre-Bénite

85925

Centre hospitalier départemental Vendée, La Roche-sur-Yon

75 571

Hôpital Saint-Antoine, Paris

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT01936532 - Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06) | Biotech Hunter | Biotech Hunter