An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and 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 Len/Dex in 28 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 Len/Dex
Last patient Last treatment of Part 2 - maximum 24 cycles (approximately 2 years) or until progression.
Torben Plesner, MD
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|