Completed

UARK 2003-18, A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma

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What is being tested

Data Collection

Who is being recruted

Blood Protein Disorders+16

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorUniversity of Arkansas
Last updated: January 27, 2026
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Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

This study will induce anti-myeloma responses in patients with high risk or relapsed myeloma using combination chemo- and immunotherapy comprising sequentially: 1) lymphoid suppressive conditioning to avoid rejection of the donor NK cells, 2) adoptive transfer of purified KIR-ligand mismatched Natural Killer cells from a haplo-identical donor, and 3) autografting two weeks after infusion of NK cells to ensure autologous reconstitution.

Official TitleUARK 2003-18, A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma
NCT00089453
Principal SponsorUniversity of Arkansas
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsVascular DiseasesHemostatic DisordersDisease AttributesNeoplasms, Plasma Cell

Criteria

13 inclusion criteria required to participate
MM in frank relapse after a single or tandem transplant or high risk Myeloma
Patients with prior transplant must be more than 4 months after the last transplant
Karnofsky performance score >or =70, or a performance score of 50-70 exclusively due to bone pain caused by myeloma
18 years of age or older
Show More Criteria
4 exclusion criteria prevent from participating
Intravenous chemotherapy or antibody therapy affecting T-lymphocytes and/or natural killer cells e.g. cyclophosphamide, melphalan, ATG, Campath-1H etc. within the past 2 weeks prior to commencement of conditioning. Last therapy is less than 14 days prior to starting fludarabine
Fever or active infection, requiring IV antibiotics
Liver function: total bilirubin > 2xULN or AST/ALT >3xULN
Renal function: patients on dialysis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Arkansas for Medical Sciences/MIRT

Little Rock, United StatesOpen University of Arkansas for Medical Sciences/MIRT in Google Maps
CompletedOne Study Center