An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The study is conducted in two parts. The dose escalation portion of the trial (Part 1)
subjects are enrolled into cohorts at increasing dose levels of daratumumab in combination
with bortezomib and dexemethasone in 21 day treatment cycles. Part 2, the cohort expansion
part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum
tested dose) of daratumumab as determined in Part 1.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone
Frequency and intensity of adverse events and laboratory measurements
Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment.
Antonio Palumbo, MD
Department of Hematology, University of Torino
United States: Food and Drug Administration