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NCT04091126 · ClinicalTrials.gov registry record · Phase 1
Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma
A Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT04091126: Active Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
NCT04091126 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 118 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04091126, 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
- 118 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
Primary Outcome
The number of participants with DLTs will be reported.
Conditions Studied
Interventions
- DRUG Belantamab mafodotin
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Bortezomib
Study Locations (20)
Other
- GSK Investigational Site - Poitiers
- GSK Investigational Site - Dresden
- GSK Investigational Site - Hamburg
- GSK Investigational Site - Schwerin
- GSK Investigational Site - Tübingen
- GSK Investigational Site - Bologna
- GSK Investigational Site - Meldola FC
- GSK Investigational Site - Lublin
- GSK Investigational Site - Poznan
- GSK Investigational Site - Seoul
- GSK Investigational Site - Seoul
- GSK Investigational Site - Seoul
Victoria
- GSK Investigational Site - Clayton
- GSK Investigational Site - Fitzroy
Kansas
- GSK Investigational Site - Westwood
North Carolina
- GSK Investigational Site - Charlotte
Wisconsin
- GSK Investigational Site - Madison
New South Wales
- GSK Investigational Site - Newcastle
Alberta
- GSK Investigational Site - Edmonton
Ontario
- GSK Investigational Site - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04091126 still lists
NCT04091126 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Belantamab mafodotin is the first listed.
NCT04091126 names 20 study sites across 8 states, led by Other, Victoria, Kansas.
Frequently Asked Questions
What is clinical trial NCT04091126 about?
NCT04091126 is a clinical study titled "Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma". This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed m...
What is the current status of trial NCT04091126?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2019-12-18. Estimated completion is 2026-12-31.
What conditions does trial NCT04091126 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04091126?
The interventions under investigation include: Belantamab mafodotin (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04091126?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04091126 being conducted?
This trial has 20 study locations across Kansas, North Carolina, Wisconsin, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04091126's enrollment target sits among peer trials
118 157th of 438 higher than 282 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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