A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

Participants will be administered intravenously with daratumumab at a dose of 8 or 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation. If the dose exceeds 24 mg/kg, then it will be considered as overdose in this study.

Trial Locations (2)

Unknown

Nagoya

Tokyo

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT02116569 - A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter