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NCT04162210 · ClinicalTrials.gov registry record · Phase 3
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
A Phase 3 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
- 20
- Study locations
NCT04162210: Active Phase 3 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
NCT04162210 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 325 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04162210, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
Primary Outcome
PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percent
Conditions Studied
Interventions
- DRUG Belantamab mafodotin
- DRUG Pom/dex (Pomalidomide plus low dose Dexamethasone)
Study Locations (20)
Other
- GSK Investigational Site - Bruges
- GSK Investigational Site - Brussels
- GSK Investigational Site - Brussels
- GSK Investigational Site - Edegem
- GSK Investigational Site - Kortrijk
Oregon
- GSK Investigational Site - Corvallis
- GSK Investigational Site - Eugene
Victoria
- GSK Investigational Site - Fitzroy
- GSK Investigational Site - Geelong
Arizona
- GSK Investigational Site - Tucson
Colorado
- GSK Investigational Site - Pueblo
Michigan
- GSK Investigational Site - Detroit
Nebraska
- GSK Investigational Site - Omaha
New York
- GSK Investigational Site - Clifton Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2027-03-11 |
| Phase | Phase 3 |
What the registry record for NCT04162210 still lists
NCT04162210 is an interventional study that assigns participants to a tested intervention. The registered 325 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 (40% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Belantamab mafodotin is the first listed.
NCT04162210 names 20 study sites across 14 states, led by Other, Oregon, Victoria.
Frequently Asked Questions
What is clinical trial NCT04162210 about?
NCT04162210 is a clinical study titled "Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)". This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will b...
What is the current status of trial NCT04162210?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2021-03-24. Estimated completion is 2027-03-11.
What conditions does trial NCT04162210 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04162210?
The interventions under investigation include: Belantamab mafodotin (DRUG), Pom/dex (Pomalidomide plus low dose Dexamethasone) (DRUG).
Who is sponsoring clinical trial NCT04162210?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04162210 being conducted?
This trial has 20 study locations across Arizona, Colorado, Michigan, Nebraska, New York. 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 NCT04162210's enrollment target sits among peer trials
325 66th of 438 higher than 372 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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