The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture
of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous
(SC) delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation)
administration via SC delivery of daratumumab (Part 2) and to evaluate the safety of
Dara-CF 1800 milligram (mg) SC delivery without pre-dose and post-dose corticosteroids
(Part 3).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02519452.
This is an open-label (identity of assigned study drug will be known), multicenter,
3-part, Phase 1b dose escalation/expansion study to evaluate the safety, pharmacokinetics
(study of what the body does to a drug), and antitumor activity of SC delivery of
daratumumab to participant with relapsed or refractory multiple myeloma. Up to
approximately 53 participants in part 1, 80 participants in part 2 and 15 participants
per corticosteroid tapering cohort (up to approximately 30 participants total) in Part 3
will be enrolled. The purpose of Part 1 is to select an appropriate SC therapeutic dose
for the mixture of daratumumab with rHuPH20 based on safety and pharmacokinetics. This
dose, selected from part 1 will be the initial dose for the co-formulated daratumumab and
rHuPH20 preparation to be evaluated in Part 2. The purpose of Part 2 is to evaluate the
SC delivery of CF and confirm the dose level selected from Part 1 based on the
pharmacokinetics, safety, and antitumor activity. The purpose of Part 3 is to evaluate
the safety of Dara-CF 1800 mg SC delivery without pre-dose and post-dose corticosteroids.
Participant's safety will be monitored throughout the study.
Lead OrganizationJanssen Pharmaceuticals
