60
Participants
Start Date
July 6, 2016
Primary Completion Date
October 18, 2022
Study Completion Date
October 18, 2022
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).
VU University Medical Center, Amsterdam
Collaborators (1)
Erasmus Medical Center
OTHER
UMC Utrecht
OTHER
University of Turin, Italy
OTHER
Vejle Hospital
OTHER
Amsterdam UMC, location VUmc
OTHER