NCT03003728

2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT)

2015-10: A Phase II Pilot Study of Expanded Natural Killer Cells and Elotuzumab to Eradicate High-Risk Myeloma Post Autologous Stem Cell Transplant

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell transplant. Natural killer cells are a special type of white blood cells that are already present in the body which have the ability to kill myeloma cells. In this study, natural killer cells will be collected and then treated in a laboratory to activate and 'expand' the number of cells to increase the dose and the anti-myeloma activity of the cells before they are transfused back into the subject. Elotuzumab is a protein drug approved by the United States Food and Drug Administration (FDA) for patients with previously treated multiple myeloma and works by activating natural killer cells already present in the body and targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma cells. The investigators hope that administering Elotuzumab in combination with ENK cells will enhance the anti-myeloma activity of the ENK cells.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elotuzumab	Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26
DRUG	Melphalan	Melphalan 200 mg/m2 Ivia intravenous infusion on day -3
PROCEDURE	Autologous Stem Cell Transplant (ASCT)	ASCT on day -2
BIOLOGICAL	Expanded Natural Killer (ENK) Cells	ENK cell infusion on day 0
DRUG	ALT-803	ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2016-12-28
• Last updated: 2020-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study