MedTrace Logo

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

NCT03003728 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-07-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Altor BioScience

    collaborator INDUSTRY

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Frits van Rhee, MD, PhD · University of Arkansas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-07-08
Completion
2020-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003728 on ClinicalTrials.gov