Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antipyretics

Analgesics

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Respiratory System Agents

Thalidomide

Antibodies

Antibodies, Monoclonal

Dexamethasone

Acetaminophen

Prednisone

Melphalan

Immunomodulating Agents

Lenalidomide

Bortezomib

Daratumumab

Pomalidomide

Dexamethasone acetate

Immunoglobulins

Diphenhydramine

Promethazine

Montelukast

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Analgesics, Non-Narcotic

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Anti-Bacterial Agents

Anti-Asthmatic Agents

Leukotriene Antagonists

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Daratumumab will be administered with Velcade-dexamethasone (VD).

Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).

Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).

Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).

Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.

Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.

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

Administered subcutaneously in accordance with product labeling and local standards.

Velcade

Administered orally in accordance with product labeling and local standards.

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

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

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

Administered intravenously in accordance with product labeling and local standards.

Carfilzomib

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

Janssen Research & Development, LLC Clinical Trial

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.

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.

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

An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma

Janssen Research & Development, LLC

Spots Global Cancer Trial Database for immunomodulatory drug