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NCT04398745 · ClinicalTrials.gov registry record · Phase 1
A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function
A Phase 1 study of Multiple Myeloma, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 19
- Study locations
NCT04398745 is a Phase 1 study of Multiple Myeloma that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 36 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% lower). The trial reports 19 study locations across 10 states.
The verdict
NCT04398745, a Phase 1 study of Multiple Myeloma, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 19
- Study locations
Study Summary
Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at initial diagnosis. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with RRMM, who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation ) and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal/mildly impaired renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD), where participants are either not undergoing or require hemodialysis. Participants will be administered belantamab mafodotin at a dose of 2.5 milligram per kilogram (mg/kg) intravenously once in three weeks (Q3W) dosing in Part 1. Based on the Part 1 Safety/Pharmacokinetic (PK) data, Part 2 participants will be administered the dose of either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose). Participants will be treated with belantamab mafodotin monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, follow-up phase and a post analysis continued treatment (PACT) phase . The total duration of the study is approximately up to 48 months.
Conditions Studied
Interventions
- DRUG Belantamab mafodotin
Study Locations (19)
Other
- GSK Investigational Site - Athens
- GSK Investigational Site - Athens
- GSK Investigational Site - Singapore
- GSK Investigational Site - Singapore
- GSK Investigational Site - Busan
- GSK Investigational Site - Incheon
- GSK Investigational Site - Seoul
- GSK Investigational Site - Seoul
California
- GSK Investigational Site - Beverly Hills
- GSK Investigational Site - Sacramento
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Plantation
Arizona
- GSK Investigational Site - Tucson
Illinois
- GSK Investigational Site - Chicago
Kansas
- GSK Investigational Site - Westwood
Maryland
- GSK Investigational Site - Baltimore
North Carolina
- GSK Investigational Site - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04398745
The ClinicalTrials.gov registry entry for NCT04398745 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (93% 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 1 intervention - of which Belantamab mafodotin is the first listed.
NCT04398745 reports 19 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04398745 about?
NCT04398745 is a clinical study titled "A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function". Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at ...
What is the current status of trial NCT04398745?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-10-09. Estimated completion is 2025-12-31.
What conditions does trial NCT04398745 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04398745?
The interventions under investigation include: Belantamab mafodotin (DRUG).
Who is sponsoring clinical trial NCT04398745?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04398745 being conducted?
This trial has 19 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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