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

Summary

The purpose of this study is to evaluate the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

DRUG

Daratumumab

Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.

DRUG

Velcade

Administered subcutaneously in accordance with product labeling and local standards.

DRUG

Pomalidomide

Administered orally in accordance with product labeling and local standards.

DRUG

Dexamethasone

Administered intravenously or orally in accordance with product labeling and local standards.

DRUG

Melphalan

Administered orally in accordance with product labeling and local standards.

DRUG

Prednisone

Administered intravenously or orally in accordance with product labeling and local standards.

DRUG

Thalidomide

Administered orally in accordance with product labeling and local standards.

DRUG

Diphenhydramine

Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.

DRUG

Acetaminophen

Administered in prophylactic doses by mouth in accordance with product labeling and local standards.

DRUG

Carfilzomib

Administered intravenously in accordance with product labeling and local standards.

DRUG

Lenalidomide

Administered orally in accordance with product labeling and local standards.

DRUG

Montelukast

Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-18

Primary Completion

2019-01-31

Completion

2024-01-11

Countries

• United States
• France
• Spain

Study Locations