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NCT01313897 · ClinicalTrials.gov registry record · Phase 2
UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma
A Phase 2 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01313897: Completed Phase 2 study, sponsored by University of Arkansas.
NCT01313897 is a Phase 2 study that has completed, run by University of Arkansas. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313897, a Phase 2 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: \>= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND \>= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if \>= 30% plasma cells at baseline);
Interventions
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT01313897 record still lists
NCT01313897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Bortezomib is the first listed.
NCT01313897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313897 about?
NCT01313897 is a clinical study titled "UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma". 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 (...
What is the current status of trial NCT01313897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-01. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01313897?
The interventions under investigation include: Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01313897?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01313897's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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