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NCT07217184 · ClinicalTrials.gov registry record · Phase 1
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM
A Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 19
- Study locations
NCT07217184: Active Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
NCT07217184 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 19 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217184, 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
- 30 participants
- Enrollment target
- 19
- Study locations
Study Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, 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 Isatuximab
Study Locations (19)
Other
- GSK Investigational Site - São Paulo
- GSK Investigational Site - Villejuif
- GSK Investigational Site - Athens
- GSK Investigational Site - Mexico City
- GSK Investigational Site - Oslo
- GSK Investigational Site - Seoul
- GSK Investigational Site - Seoul
- GSK Investigational Site - Ulsan
- GSK Investigational Site - Madrid
- GSK Investigational Site - Madrid
- GSK Investigational Site - Pozuelo de AlarcOn Madr
- GSK Investigational Site - Falun
Georgia
- GSK Investigational Site - Atlanta
Massachusetts
- GSK Investigational Site - Boston
Michigan
- GSK Investigational Site - Grand Rapids
Wisconsin
- GSK Investigational Site - Madison
Victoria
- GSK Investigational Site - Fitzroy
Estado de Bahia
- GSK Investigational Site - Salvador
Ontario
- GSK Investigational Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2027-03-11 |
| Phase | Phase 1 |
What the registry record for NCT07217184 still lists
NCT07217184 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 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.
NCT07217184 lists 19 locations in 8 states (Other, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07217184 about?
NCT07217184 is a clinical study titled "Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM". The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, 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 stud...
What is the current status of trial NCT07217184?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-07-29. Estimated completion is 2027-03-11.
What conditions does trial NCT07217184 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT07217184?
The interventions under investigation include: Belantamab mafodotin (DRUG), Isatuximab (DRUG).
Who is sponsoring clinical trial NCT07217184?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217184 being conducted?
This trial has 19 study locations across Georgia, Massachusetts, Michigan, Wisconsin, Victoria. 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 NCT07217184's enrollment target sits among peer trials
30 338th of 438 higher than 80 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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