NCT04398745: Phase 1: Belantamab Mafodotin With Normal and Varying Degree of Impaired Renal Function
- Recruiting
- Dec 23, 2021
- 3 min read
Updated: Sep 19, 2022
DREAMM 12
Relapsed & Refractory Myeloma
NCT04398745: Phase 1: A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function (DREAMM 12)
Belantamab mafodotin (GSK2857916) 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 majority of MM participants are either at risk or already have 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 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 GSK2857916 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 GSK2857916 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, and follow- up phase. The total duration of the study is approximately up to 48 months.
Sponsor
ClinicalTrials.gov Identifier: NCT04398745
A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function (DREAMM 12)
First Posted : May 21, 2020
Click here to see details on ClinicalTrials.gov
Drug: Belantamab mafodotin
GSK2857916
Locations
United States, Arizona
United States, California
United States, Florida
United States, Illinois
United States, Kansas
United States, Maryland
United States, Michigan
United States, New Jersey
United States, New York
United States, North Carolina
United States, Oregon
United States, Pennsylvania
United States, Texas
United States, Wisconsin
Europe
Greece
Asia
Korea, Republic of
Singapore
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