A Phase I Study of AMG 224 in Patients with Persistent or Recurrent Multiple Myeloma

Full Title

20130314: A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects with Relapsed or Refractory Multiple Myeloma

Purpose

The purpose of this study is to find the highest dose of the investigational drug AMG 224 that can be given safely in patients with multiple myeloma that has come back or continued to grow despite previous treatment. AMG 224 is an antibody-drug conjugate. This means it contains an antibody that binds to a protein on multiple myeloma cells (in this case, a protein called BCMA) as well as an anticancer drug, which is released once it reaches the tumor cell. AMG 224 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 persistent or recurrent multiple myeloma after at least three lines of prior treatment that included a proteasome inhibitor (like bortezomib) and immunomodulatory drugs (such as lenalidomide).
  • At least 4 weeks must pass between the completion of previous anticancer treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ola Landgren at 212-639-5153.

Protocol

17-324

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators