The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in Relapsed/Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in matched RRMM participants with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Belantamab mafodotin will be administered
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Beverly Hills, California, United States
Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of Belantamab Mafodotin
Time frame: Up to 48 months
Part 1 and Part 2: Time to Cmax (Tmax) of Belantamab Mafodotin
Time frame: Up to 48 months
Part 1 and Part 2: Concentration at the end of infusion (C-EOI)
Time frame: Up to 48 months
Part 1 and Part 2: Predose plasma concentration (Ctrough) of Belantamab Mafodotin
Time frame: Up to 48 months
Part 1 and Part 2: Area under the plasma concentration-time curve (from zero to the end of dosing interval)
Time frame: Up to 48 months
Part 1 and Part 2: Last time point where the concentration is above the limit of quantification (Tlast) of Belantamab Mafodotin
Time frame: Up to 48 months
Part 1 and Part 2: Cmax of total monoclonal antibody (mAb)
Time frame: Up to 48 months
Part 1 and Part 2: Tmax of total mAb
Time frame: Up to 48 months
Part 1 and Part 2: C-EOI of total mAB
Time frame: Up to 48 months
Part 1 and Part 2: Ctrough of total mAb
Time frame: Up to 48 months
Part 1 and Part 2: Area under the plasma concentration-time curve (from zero to the end of dosing interval)of total mAb
Time frame: Up to 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Plantation, Florida, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Monroeville, Pennsylvania, United States
GSK Investigational Site
The Woodlands, Texas, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Daegu, South Korea
...and 8 more locations
Part 1 and Part 2: Tlast of total mAb
Time frame: Up to 48 months
Part 1 and Part 2: Cmax of Cys Monomethyl Auristatin F (cys-mcMMAF)
Time frame: Up to 48 months
Part 1 and Part 2: Tmax of cys-mcMMAF
Time frame: Up to 48 months
Part 1 and Part 2: C-EOI of cys-mcMMAF
Time frame: Up to 48 months
Part 1 and Part 2: AUC(0-168 hours) of cys-mcMMAF
Time frame: Up to 48 months
Part 1 and Part 2: tlast of cys-mcMMAF
Time frame: Up to 48 months
Part 1 and Part 2: Change from Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (millimeters of mercury [mmHg])
Time frame: Baseline and up to 4 years
Part 1 and Part 2: Change from Baseline in Vital Sign- Heart rate (beats per minute)
Time frame: Baseline and up to 4 years
Part 1 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 4 years
Part 1 and Part 2: Number of participants with toxicity grading for hematology parameters
Time frame: Up to 4 years
Part 1 and Part 2: Number of participants with toxicity grading for clinical chemistry parameters
Time frame: Up to 4 years
Part 1 and Part 2: Number of participants with toxicity grading for urine parameters
Time frame: Up to 4 years