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NCT05514990 · ClinicalTrials.gov registry record · Phase 1
Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
A Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by University of Southern California.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT05514990: Active Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by University of Southern California.
NCT05514990 is a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 10 participants, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05514990, a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I/II trial studies the safety of the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Chemotherapy drugs, such as bortezomib and 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 modified in the laboratory, such as pelareorep, may be able to kill cancer cells without damaging normal cells. Giving the combination of bortezomib, dexamethasone, and pembrolizumab with pelareorep may work better in treating patient with multiple myeloma.
Primary Outcome
Incidence of dose-limiting toxicities resulting from pelareorep (PELA) in combination with bortezomib-dexamethasone (BOR-D) and pembrolizumab will be assessed. Severity of Adverse Events (AEs) will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Dexamethasone
- DRUG Bortezomib
- BIOLOGICAL Pelareorep
Study Locations (2)
California
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-10-07 |
| Est. Completion | 2027-08-22 |
| Phase | Phase 1 |
What the registry record for NCT05514990 still lists
NCT05514990 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 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT05514990 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05514990 about?
NCT05514990 is a clinical study titled "Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial". This phase I/II trial studies the safety of the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Chemotherapy drugs, such as bortezomib and d...
What is the current status of trial NCT05514990?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-10-07. Estimated completion is 2027-08-22.
What conditions does trial NCT05514990 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma.
What interventions are being tested in trial NCT05514990?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Dexamethasone (DRUG), Bortezomib (DRUG), Pelareorep (BIOLOGICAL).
Who is sponsoring clinical trial NCT05514990?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05514990 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell Myeloma
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Where NCT05514990's enrollment target sits among peer trials
10 22nd of 25 higher than 4 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell Myeloma 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.
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