NCT02519452: Phase 1 - Daratumumab + Recombinant Human Hyaluronidase (rHuPH20) RRMM - PAVO Study
Updated: May 6, 2022
MMY1004 (PAVO) Study
RRMM
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).
Drug: Daratumumab Subcutaneous (SC) Administration
Drug: Recombinant Human Hyaluronidase [rHuPH20]) SC Administration
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT02519452
Blood; Aug 2019
Subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: Part 2 of the open-label, multicenter, dose-escalation phase 1b study (PAVO) Haematologica. 2021
* Daratumumab (Darzalex)
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