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UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma

NCT01313897 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-05-19

Study results available
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Summary

The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy in research participants with relapsed high risk MM \[defined as gene expression profile (GEP) 70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L\] by establishing the (near) complete response rate. Response rate will be compared to case matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM defined as above). Disease-free survival and overall survival will be captured but are not primary or secondary endpoints.

Conditions

Interventions

DRUG

Bortezomib

bortezomib to be given days -9, -6, and -2 at 1.0mg/m2, i.v.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Frits van Rhee, M.D., PHD. · University of Arkansas

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-10-31
Completion
2016-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01313897 on ClinicalTrials.gov