A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 22, 2015

Primary Completion Date

December 13, 2017

Study Completion Date

April 3, 2023

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab Subcutaneous (SC) Administration

Participants will receive Daratumumab mixed with rHuPH20 in part 1 and co-formulated with rHuPH20 in part 2 and part 3 administered via SC administration once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles.

DRUG

Recombinant Human Hyaluronidase [rHuPH20]) SC Administration

Participants will receive Recombinant Human Hyaluronidase \[rHuPH20\]) mixed with Daratumumab in part 1 and co-formulated with Daratumumab in part 2 and part 3 administered as SC administration once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles.

Trial Locations (12)

Unknown

Atlanta

New York

Charlotte

Philadelphia

Vejle

Nantes

Tours

Amsterdam

Badalona

Pamplona

Salamanca

Stockholm

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02519452 - A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter