• Active, not recruiting

NCT01998971: Phase 1 - JNJ-54767414 (HuMax CD38) (Anti-CD38 Mono. Ab. ) in Myeloma EQUULEUS; MMY1001

Updated: May 19

Phase 1 b EQUULEUS study

EQUULEUS; MMY1001 Study

EQUULEUS

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

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


JNJ-54767414 - National Cancer Institute

 

Dara + Vd

Dara + Kd

Dara + Pd

Dara + KRd

Dara + VTd

Dara + VMP

 

PMID: 28637662

Blood; Aug 2017

Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma


PMID: 31113777

Blood; Aug 2019

Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma



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