NCT01998971: Phase 1 - JNJ-54767414 (HuMax CD38) (Anti-CD38 Mono. Ab. ) in Myeloma EQUULEUS; MMY1001
Updated: May 19, 2022
Phase 1 b EQUULEUS study
EQUULEUS; MMY1001 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
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 subjects per VTD and VMP backbone treatment regimen, 6 for the VD regimen, up to 100 subjects in the Pom-dex regimen, 80 for the CFZ-dex regimen [10 subjects will receive a single-dose of daratumumab and the remaining subjects 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 until disease progression (in the Pom-dex and CFZ-dex regimen). Follow-up will continue until the study ends (approximately 15 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.
JNJ-54767414
Drug: Daratumumab
Drug: Velcade
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Thalidomide
Drug: Diphenhydramine
Drug: Acetaminophen
Drug: Carfilzomib
Drug: Lenalidomide
Drug: Montelukast
ClinicalTrials.gov Identifier: NCT01998971
Official Title: 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
First Posted : December 3, 2013
Click here to see details on ClinicalTrials.gov
Dara + Vd
Dara + Kd
Dara + Pd
Dara + KRd
Dara + VTd
Dara + VMP
PMID: 28637662
Blood; Aug 2017
PMID: 31113777
Blood; Aug 2019