Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

September 30, 2022

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Multiple Myeloma
Interventions
DRUG

Iberdomide

Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO)

DRUG

Dexamethasone

Dexamethasone 40 mg (PO) (or 20 mg (PO) if patient ≥ 75 years old) should be administered on the days 1, 8, 15 and 22 of every 4-week cycle.

DRUG

Daratumumab

Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days).

Trial Locations (9)

Unknown

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Son Llatzer, Palma de Mallorca

Clínica Universidad de Navarra, Pamplona

Hospital Universitario de Salamanca, Salamanca

Hospital Universitario de Canarias, San Cristóbal de La Laguna

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Universitario Virgen del Rocío, Seville

Hospital Universitario y Politécnico La Fe de Valencia, Valencia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene-BMS

UNKNOWN

collaborator

Janssen-Cilag, S.A.

INDUSTRY

collaborator

LIDESEC

UNKNOWN

lead

PETHEMA Foundation

OTHER