Daratumumab in Combination With ATRA

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 6, 2016

Primary Completion Date

October 18, 2022

Study Completion Date

October 18, 2022

Conditions
Multiple Myeloma
Interventions
DRUG

all-trans retinoic acid (ATRA)

Phase 1 and 2: daratumumab 16 mg/kg, first 8 infusions are given weekly, then 8 infusions every 3 weeks, then every 4 weeks until progression Phase 1: ATRA 15, 30, or 45 mg/m2/day for 3 days. Phase 2: ATRA will be administered twice daily as an oral formulation at the MTD dose, or if no MTD is reached, at the dose of 45 mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled daratumumab infusion. The last administration of ATRA will be given in the evening of the day that daratumumab was administered (days -2, -1, and 0; day 0 is the day of daratumumab infusion).

Trial Locations (1)

1081HV

VU University Medical Center, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

University of Turin, Italy

OTHER

collaborator

Vejle Hospital

OTHER

lead

Amsterdam UMC, location VUmc

OTHER