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NCT03525678 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
A Phase 2 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
- 20
- Study locations
NCT03525678 is a Phase 2 study of Multiple Myeloma that has completed, run by GlaxoSmithKline. The registered enrollment target is 221 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT03525678, a Phase 2 study of Multiple Myeloma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
- 20
- Study locations
Study Summary
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.
Conditions Studied
Interventions
- DRUG Belantamab mafodotin frozen liquid
- DRUG Belantamab mafodotin lyophilized powder
Study Locations (20)
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Atlanta
Illinois
- GSK Investigational Site - Chicago
- GSK Investigational Site - Chicago
New York
- GSK Investigational Site - New York
- GSK Investigational Site - New York
Connecticut
- GSK Investigational Site - New Haven
Indiana
- GSK Investigational Site - Indianapolis
Kansas
- GSK Investigational Site - Fairway
Louisiana
- GSK Investigational Site - Baton Rouge
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525678
The ClinicalTrials.gov registry entry for NCT03525678 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (60% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Belantamab mafodotin frozen liquid is the first listed.
NCT03525678 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Georgia, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT03525678 about?
NCT03525678 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody". Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GS...
What is the current status of trial NCT03525678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2018-06-18. Estimated completion is 2024-09-12.
What conditions does trial NCT03525678 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03525678?
The interventions under investigation include: Belantamab mafodotin frozen liquid (DRUG), Belantamab mafodotin lyophilized powder (DRUG).
Who is sponsoring clinical trial NCT03525678?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03525678 being conducted?
This trial has 20 study locations across Connecticut, Georgia, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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