Halozyme Therapeutics Inc (HALO)

[rod5247]

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma


This study is not yet open for participant recruitment.
See Contacts and Locations

Verified September 2017 by Janssen Research & Development, LLC

Sponsor:

Janssen Research & Development, LLC

Information provided by (Responsible Party):

Janssen Research & Development, LLC


ClinicalTrials.gov Identifier:

NCT03277105

First received: September 7, 2017

Last updated: NA

Last verified: September 2017

History: No changes posted

Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record



Purpose

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).




Condition

Intervention

Phase


Multiple Myeloma

Drug: Dara SC

Drug: Dara IV

Phase 3







Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma