Who is sponsoring NCT03277105?

NCT03277105 is sponsored by Janssen Research & Development, LLC.

What condition does NCT03277105 study?

NCT03277105 studies Multiple Myeloma.

What drugs are being tested in NCT03277105?

Interventions: Dara SC, Dara IV.

What is the status of NCT03277105?

NCT03277105 is currently COMPLETED.

Last reviewed 2025-04-29 · How we verify

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

NCT03277105 PHASE3 COMPLETED Results posted

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).

Details

Lead sponsor	Janssen Research & Development, LLC
Phase	PHASE3
Status	COMPLETED
Enrolment	522
Start date	Fri Oct 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Multiple Myeloma

Interventions

Dara SC
Dara IV

Countries

France, Italy, Japan, Russia, Greece, Ukraine, Sweden, Taiwan, United Kingdom, Israel, Poland, South Korea, Canada, Australia, Spain, United States, Brazil, Czechia