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NCT03605719 · ClinicalTrials.gov registry record · Phase 1
Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03605719: Completed Phase 1 study, sponsored by Emory University.
NCT03605719 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605719, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of wild-type reovirus (pelareorep) when given together with dexamethasone, carfilzomib, and nivolumab in treating patients with multiple myeloma that has come back (relapsed). Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. A virus, called pelareorep, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Giving dexamethasone, carfilzomib, and nivolumab with pelareorep may work better in treating patients with multiple myeloma.
Primary Outcome
A DLT is defined as one of the following toxicities: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/µL) lasting 5 days or more. * Grade 3 to 4 thrombocytopenia associated with bleeding requiring platelet transfusion * Cardiac dysfunction: Grade \> 3 left ventricular systolic dysfunction or grade \> 2 myocarditis * Any grade 3-4 treatment-emergent non-hematologic adverse event (AE) clearly unrelated to the underlying disease and considered to be at least possibly related to prot
Interventions
- DRUG Dexamethasone
- BIOLOGICAL Nivolumab
- DRUG Carfilzomib
- BIOLOGICAL Pelareorep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2022-10-10 |
| Phase | Phase 1 |
What the finished NCT03605719 record still lists
NCT03605719 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT03605719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605719 about?
NCT03605719 is a clinical study titled "Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma". This phase I trial studies the side effects and best dose of wild-type reovirus (pelareorep) when given together with dexamethasone, carfilzomib, and nivolumab in treating patients with multiple myeloma that has come back (relapsed). Drugs used in chemotherapy, such as dexamethasone, work in differe...
What is the current status of trial NCT03605719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2018-10-24. Estimated completion is 2022-10-10.
What interventions are being tested in trial NCT03605719?
The interventions under investigation include: Dexamethasone (DRUG), Nivolumab (BIOLOGICAL), Carfilzomib (DRUG), Pelareorep (BIOLOGICAL).
Who is sponsoring clinical trial NCT03605719?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03605719's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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