NCT02519452: Phase 1 - Daratumumab + Recombinant Human Hyaluronidase (rHuPH20) RRMM - PAVO Study

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

Official Title: An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma

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Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information

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Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma

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

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* Daratumumab (Darzalex)