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NCT01248455 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01248455: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01248455 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01248455, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: * Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. People with smoldering multiple myeloma have abnormal blood test results that show a high level of monoclonal protein (M-protein) in the blood and of plasma cells in the bone marrow. There are currently no known effective treatments to prevent smoldering multiple myeloma from developing into multiple myeloma, and there are no known tests for determining whether an individual with smoldering multiple myeloma will develop multiple myeloma. * Certain cells in the immune system, known as natural killer (NK) cells, are active against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells. Researchers are interested in determining whether anti-KIR can be given to individuals with smoldering multiple myeloma to improve their abnormal blood test results. Objectives: \- To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test results related to smoldering multiple myeloma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with smoldering multiple myeloma. Design: * Participants will be screened with a physical examination and medical history, and will provide baseline blood, urine, and bone marrow samples before beginning the study drug. * Participants will receive anti-KIR intravenously for 1 hour, and will be closely monitored for 24 hours after receiving the first dose. If there are no serious side effects, participants will receive five additional anti-KIR doses, one every other month, for a total of six treatment cycles. * Participants will have monthly visits to provide additional blood and urine samples, and may have additional bone marrow biopsies as directed by the study researchers. * Participants will ha
Primary Outcome
Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR \>25% and \<50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progr
Interventions
- DRUG (Anti-KIR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-11-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01248455 stopped before completion
NCT01248455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which (Anti-KIR) is the first listed.
NCT01248455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01248455 about?
NCT01248455 is a clinical study titled "A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma". Background: * Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. People with smoldering multiple myeloma have abnormal blood test results that show a high level of mono...
What is the current status of trial NCT01248455?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2010-11-01. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01248455?
The interventions under investigation include: (Anti-KIR) (DRUG).
Who is sponsoring clinical trial NCT01248455?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01248455's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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