Research Study

A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Subjects With Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA
Principal Investigator 
Heather J. Sutherland

Overview

Body Locations and Systems 
Blood
Disorders and Conditions 
Multiple Myeloma
ClinicalTrials.gov# 
NCT02064387
Status 
Closed to Recruitment
Study Start/End 
Oct 2, 2015 to Jun 1, 2017
Locations 
Vancouver General Hospital
Name/Title 
Cindy Manchulenko, Research Coordinator
Phone 
604-875-4111 ext.67227
Purpose of Study 

This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and other hematologic malignancies that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with BCMA positive malignancies at doses where target engagement can be demonstrated. This study will determine if adequate target engagement of BCMA receptors translates into clinical benefit for subjects with MM and other BCMA positive hematologic malignancies. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, and clinical activity testing. The study will enroll a total of approximately 80 subjects with relapsed/refractory MM or other BCMA-expressing hematologic malignancies.

Eligibility 

Visit ClinicalTrials.gov for more information.

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.