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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: Completed Phase 2 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is \[i.e.\], PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]). Confidence intervals were based on the exact method.
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 |
What the finished NCT03525678 record still lists
NCT03525678 is an interventional study that assigns participants to a tested intervention. The registered 221 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 (60% lower).
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 names 20 study sites across 17 states, led by 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.
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 NCT03525678's enrollment target sits among peer trials
221 102nd of 438 higher than 337 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.
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