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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. 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
Interventions
- DRUG (Anti-KIR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-11-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248455
The ClinicalTrials.gov registry entry for NCT01248455 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which (Anti-KIR) is the first listed.
NCT01248455 reports 0 study locations.
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.
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