A Phase I Study of GSK2857916 in Patients with Recurrent or Persistent Multiple Myeloma

Full Title

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

Purpose

The purpose of this study is to find the highest dose of the investigational drug GSK2857916 that can be given safely in patients with multiple myeloma that has returned or continued to grow despite treatment. GSK2857916 is called an antibody-drug conjugate. It contains two parts: an antibody that attaches to a protein on multiple myeloma cells called B-cell maturation antigen (BCMA), and an anticancer drug that damages the myeloma cells to which the antibody has attached.

GSK2857916 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma which has come back or continued to grow despite prior treatment that included alkylator, proteosome inhibitor, and immunomodulator drugs.
  • Patients must have previously had an autologous (self) stem cell transplant or be ineligible for a stem cell transplant.
  • Patients’ multiple myeloma must have continued to grow within 60 days of completing the last therapy before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nikoletta Lendvai at 212-639-3368.

Protocol

14-105

Phase

I

Investigator

Co-Investigators

Locations