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NCT07217119 · ClinicalTrials.gov registry record · Phase 1
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM
A Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 11
- Study locations
NCT07217119: Active Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
NCT07217119 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 25 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217119, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 11
- Study locations
Study Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with feladilimab (GSK3359609), and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Primary Outcome
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal to
Conditions Studied
Interventions
- DRUG Belantamab mafodotin
- DRUG Feladilimab
Study Locations (11)
Other
- GSK Investigational Site - Villejuif
- GSK Investigational Site - Hamburg
- GSK Investigational Site - Utrecht
- GSK Investigational Site - Pamplona Navarra
- GSK Investigational Site - Stockholm
Victoria
- GSK Investigational Site - Fitzroy
- GSK Investigational Site - Melbourne
Georgia
- GSK Investigational Site - Atlanta
Wisconsin
- GSK Investigational Site - Madison
British Columbia
- GSK Investigational Site - Vancouver
Ontario
- GSK Investigational Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2027-03-11 |
| Phase | Phase 1 |
What the registry record for NCT07217119 still lists
NCT07217119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Belantamab mafodotin is the first listed.
NCT07217119 lists 11 locations in 6 states (Other, Victoria, Georgia).
Frequently Asked Questions
What is clinical trial NCT07217119 about?
NCT07217119 is a clinical study titled "Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM". The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with feladilimab (GSK3359609), and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study...
What is the current status of trial NCT07217119?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-11-26. Estimated completion is 2027-03-11.
What conditions does trial NCT07217119 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT07217119?
The interventions under investigation include: Belantamab mafodotin (DRUG), Feladilimab (DRUG).
Who is sponsoring clinical trial NCT07217119?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217119 being conducted?
This trial has 11 study locations across Georgia, Wisconsin, Victoria, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
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Where NCT07217119's enrollment target sits among peer trials
25 366th of 438 higher than 63 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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