A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

This is an open-label (identity of assigned study drug will be known) study to evaluate

the safety, tolerability, and dose of daratumumab when administered in combination with

various treatment regimens for different settings of multiple myeloma. The various

treatment regimens to be combined with daratumumab in this study include

Velcade-dexamethasone (VD), Velcade-melphalan-prednisone (VMP),

Velcade-thalidomide-dexamethasone (VTD), pomalidomide-dexamethasone (Pom-dex),

carfilzomib-dexamethasone (CFZ-dex) and carfilzomib-lenalidomide-dexamethasone (KRd).

Approximately 250 patients (approximately 12 participants per VTD and VMP backbone

treatment regimen, 6 for the VD regimen, up to 100 participants in the Pom-dex regimen,

80 for the CFZ-dex regimen [10 participants will receive a single-dose of daratumumab and

the remaining participants will receive a split-dose of daratumumab], and up to 40 for

the KRd regimen) will be enrolled in this study. The study will consist of screening,

treatment, and follow-up phases. Treatment will extend to either the planned treatment

duration for a maximum of 1 year (in Velcade-dexamethasone, Velcade-melphalan-prednisone,

Velcade-thalidomide-dexamethasone regimens and KRd regimens), or in the Pom-dex and

CFZ-dex regimens, until disease progression, unacceptable toxicity, or until the end of

study. Follow-up will continue until the study ends (approximately 25 months after the

last patient receives the first dose of daratumumab). Serial pharmacokinetic (study of

what a drug does to the body) blood samples will be collected. Clinical efficacy outcomes

and safety will be monitored throughout the study.