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NCT05847569 · ClinicalTrials.gov registry record · Phase 2
Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
A Phase 2 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT05847569: Recruiting Phase 2 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, sponsored by Mayo Clinic.
NCT05847569 is a Phase 2 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 62 participants, above the 47-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (32% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05847569, a Phase 2 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.
Primary Outcome
The proportion of successes will be estimated by the number of successes (proportion of patients free of grade 3/4 keratopathy at the time of dose #4) divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If both arms prove to meet the primary endpoint, they will be evaluated indirectly in relation to each other similar, to a Bayesian pick the winner, approach if only one can
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Bone Marrow Aspirate
- BIOLOGICAL Belantamab Mafodotin
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2024-01-04 |
| Est. Completion | 2034-06-29 |
| Phase | Phase 2 |
What NCT05847569 shows while recruiting
NCT05847569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, above the 47-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (32% higher).
The record links to 2 conditions, with Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05847569 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05847569 about?
NCT05847569 is a clinical study titled "Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma". This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refrac...
What is the current status of trial NCT05847569?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2024-01-04. Estimated completion is 2034-06-29.
What conditions does trial NCT05847569 study?
This clinical trial studies the following conditions: Refractory Multiple Myeloma, Recurrent Multiple Myeloma.
What interventions are being tested in trial NCT05847569?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Bone Marrow Aspirate (PROCEDURE), Belantamab Mafodotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT05847569?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05847569 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05847569's enrollment target sits among peer trials
62 8th of 67 higher than 60 of 67 other Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Multiple 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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