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NCT03544281 · ClinicalTrials.gov registry record · Phase 1
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT03544281: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03544281 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03544281, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone \[Len/Dex (Treatment A)\] or Bortezomib Plus Dexamethasone \[Bor/Dex (Treatment B)\] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
Primary Outcome
DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist \>48 h despite supportive treatment or
Interventions
- DRUG Belantamab mafodotin
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 1 |
What the finished NCT03544281 record still lists
NCT03544281 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 4 interventions - of which Belantamab mafodotin is the first listed.
NCT03544281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03544281 about?
NCT03544281 is a clinical study titled "To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)". This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone \[Len/Dex (Treatment A)\] or Bortezomib Plus Dexamethasone \[Bor/Dex (Treatment B)\] in participants with RRMM, i.e.,...
What is the current status of trial NCT03544281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2018-09-20. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT03544281?
The interventions under investigation include: Belantamab mafodotin (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT03544281?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03544281's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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