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NCT02943473 · ClinicalTrials.gov registry record · Phase 2
Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT02943473 is a Phase 2 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 9 participants.
The verdict
NCT02943473, a Phase 2 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to test whether the drug ibrutinib (trademark name: IMBRUVICA®) is effective at preventing the development of multiple myeloma in people who currently have smoldering myeloma. The researchers conducting this trial) have reason to believe that ibrutinib can delay the development of multiple myeloma, thus giving people who currently have smoldering myeloma a longer period of time when they feel healthy and well. Smoldering myeloma is an abnormal condition that is considered to be an early phase of the disease multiple myeloma. In this disorder, there is an abnormal growth of plasma cells, which is a type of blood cell found in the bone marrow. This growth is not as severe in people with smoldering myeloma as it is in multiple myeloma, so people with smoldering myeloma do not have any symptoms and tend to feel well. However, they have a higher risk of developing multiple myeloma than people in the general population. Some people with smoldering myeloma are at an especially high risk of developing myeloma - 50% of these people will develop multiple myeloma 2 years after they are diagnosed with smoldering myeloma. The investigators identify these people by looking at the amount of myeloma in the bone marrow (called "bone marrow plasma cell percentage") and the amount of myeloma protein (called "serum protein electrophoresis" and "serum free light chain assay") in the blood. To be considered high risk, individuals must have highly abnormal levels for these tests. Based upon current guidelines, people with smoldering myeloma do not require any treatment. However, known is that many of these people will develop multiple myeloma in the near future. Currently there have been no proven and effective way of preventing these people from developing multiple myeloma, which remains an incurable disease.
Interventions
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-05-18 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02943473
The ClinicalTrials.gov registry entry for NCT02943473 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 Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ibrutinib is the first listed.
NCT02943473 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02943473 about?
NCT02943473 is a clinical study titled "Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma Patients". The purpose of this research study is to test whether the drug ibrutinib (trademark name: IMBRUVICA®) is effective at preventing the development of multiple myeloma in people who currently have smoldering myeloma. The researchers conducting this trial) have reason to believe that ibrutinib can delay...
What is the current status of trial NCT02943473?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-05-18. Estimated completion is 2019-09-10.
What interventions are being tested in trial NCT02943473?
The interventions under investigation include: Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02943473?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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