A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

October 31, 2017

Study Completion Date

March 31, 2020

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab (16 mg/kg)

Daratumumab (16 mg/kg) will be administered by IV infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.

DRUG

Lenalidomide

Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants with creatinine clearance (CrCl) between 30 and 60 milliLitre (mL)/minute (min) will receive lenalidomide 10 mg every 24 hours.

DRUG

Dexamethasone

Participants will receive dexamethasone 40 mg weekly, at day 1, 8, 15, 22 of each cycle.

Trial Locations (5)

Unknown

Hiroshima

Kanazawa

Nagoya

Osaka

Shibuya City

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY