• Active, not recruiting

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

Updated: May 6

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

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information

 

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


 

* Daratumumab (Darzalex)

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