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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 153 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03544281
The ClinicalTrials.gov registry entry for NCT03544281 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Belantamab mafodotin is the first listed.
NCT03544281 reports 0 study locations.
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.
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