Spots Global Cancer Trial Database for QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase I/II Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
Study ID: NCT02099539
Conditions
Interventions
Study Description
Brief Summary: This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in patients with relapsed or refractory multiple myeloma.
Detailed Description: The purpose of this study is to evaluate the safety, determine the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and characterize the immunogenicity and pharmacokinetic profile of ALT-803 in treated patients. The effect of ALT-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells will be evaluated. The anti-tumor responses of ALT-803 will also be assessed in this trial.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Contact Details
Name: Hing C Wong, PhD
Affiliation: Altor BioScience
Role: STUDY_CHAIR
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