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NCT05055063 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
A Phase 1 study of Myeloma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05055063: Recruiting Phase 1 study of Myeloma, sponsored by M.D. Anderson Cancer Center.
NCT05055063 is a Phase 1 study of Myeloma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 99-participant average among 29 other Myeloma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05055063, a Phase 1 study of Myeloma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.
Conditions Studied
Interventions
- DRUG Belantamab mafodotin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 1 |
What NCT05055063 shows while recruiting
NCT05055063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 99-participant average among 29 other Myeloma trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Belantamab mafodotin is the first listed.
NCT05055063 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05055063 about?
NCT05055063 is a clinical study titled "A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma". This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion pa...
What is the current status of trial NCT05055063?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-05-18. Estimated completion is 2027-02-02.
What conditions does trial NCT05055063 study?
This clinical trial studies the following conditions: Myeloma.
What interventions are being tested in trial NCT05055063?
The interventions under investigation include: Belantamab mafodotin (DRUG).
Who is sponsoring clinical trial NCT05055063?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05055063 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05055063's enrollment target sits among peer trials
30 23rd of 29 higher than 5 of 29 other Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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