A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 10, 2015

Primary Completion Date

March 6, 2018

Study Completion Date

March 6, 2018

Conditions
Multiple Myeloma
Interventions
DRUG

JNJ-54767414 (Daratumumab)

JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks). First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles.

DRUG

Bortezomib

Bortezomib will be administered at a dose of 1.3 mg/m\^2 subcutaneously (SC) on Day 1, 4, 8 and 11 of each 21-day cycle. Eight Bortezomib treatment cycles are to be administered.

DRUG

Dexamethasone

Dexamethasone will be administered orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles (except for Cycles 1-3). In Cycles 1-3, participants receive dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, 12 and 15. During weeks when the participants receives an infusion of daratumumab, dexamethasone will be administered at a dose of 20 mg IV or orally (PO) (only if IV is not available) before the daratumumab infusion as preinfusion medication.

Trial Locations (5)

Unknown

Hiroshima

Hitachi

Nagoya

Shibuya City

Tachikawa

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT02497378 - A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter