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A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Impaired Hepatic Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398680
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Impaired hepatic function may alter the pharmacokinetics (PK) and pharmacodynamics (PD) of belantamab mafodotin, a drug that is primarily hepatically eliminated and hence may require adjustments in dosing regimens as compared to patients who have normal hepatic function. The purpose of this study is assess the 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. The study will consist of two parts: Part 1 will include participants with normal hepatic function and moderate hepatic impairment and Part 2 will include participants with severe hepatic impairment. Participants will be administered GSK2857916 at a dose of 2.5 milligram per kilogram (mg/kg) intravenously in Part 1 and in Part 2, dose will depend on the evaluation of pharmacokinetic and safety data of Part 1. However, dose in Part 2 will not exceed 2.5 mg/kg. 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Belantamab mafodotin Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This is an open-label study.
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants With Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Hepatic Function (DREAMM 13)
Estimated Study Start Date : October 16, 2020
Estimated Primary Completion Date : May 6, 2024
Estimated Study Completion Date : May 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Part 1: Participants with normal hepatic function
Participants with normal hepatic function (Serum bilirubin and Aspartate aminotransferase [AST] <= Upper limit of normal [ULN]) will be administered with Belantamab mafodotin 2.5 mg/kg intravenous infusion over 30 minutes on Day 1 of every 21-day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Drug: Belantamab mafodotin
Belantamab mafodotin will be provided as lyophilized powder which will be available as 100 milligrams per vial (mg/vial) in single-use vial for reconstitution. Lyophilized Belantamab mafodotin will reconstituted using water for injection, dilute with saline before use.

Experimental: Part 1: Participants with moderate hepatic impairment
Participants with moderate hepatic impairment (Serum bilirubin >1.5 - 3 × ULN and any AST) will be administered with Belantamab mafodotin 2.5 mg/kg intravenous infusion over 30 minutes on Day 1 of every 21-day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Drug: Belantamab mafodotin
Belantamab mafodotin will be provided as lyophilized powder which will be available as 100 milligrams per vial (mg/vial) in single-use vial for reconstitution. Lyophilized Belantamab mafodotin will reconstituted using water for injection, dilute with saline before use.

Experimental: Part 2: Participants with severe hepatic impairment
Participants with severe hepatic impairment (Serum bilirubin >3 × ULN and any AST) will be administered with Belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other lower adjusted dose) intravenous infusion over 30 minutes on Day 1 of every 21-day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.
Drug: Belantamab mafodotin
Belantamab mafodotin will be provided as lyophilized powder which will be available as 100 milligrams per vial (mg/vial) in single-use vial for reconstitution. Lyophilized Belantamab mafodotin will reconstituted using water for injection, dilute with saline before use.




Primary Outcome Measures :
  1. Part 1: Maximum observed plasma concentration (Cmax) of GSK2857916 [ Time Frame: Cycle1:predose,end infusion (EOI), 2, 4, 8, 24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  2. Part 1: Time to Cmax (Tmax) of GSK2857916 [ Time Frame: Cycle1:predose,end infusion (EOI), 2, 4, 8, 24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  3. Part 1: Predose plasma concentration (Ctrough) of GSK2857916 [ Time Frame: Predose on Cycles 1, 2 and 3 (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  4. Part 1: Area under the plasma concentration-time curve (AUC[0-t]) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  5. Part 1: AUC over the dosing interval (AUC[0-tau]) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  6. Part 1: AUC from time zero extrapolated to infinite time (AUC[0-infinity]) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  7. Part 1: Last time point where the concentration is above the limit of quantification (Tlast) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  8. Part 1: Systemic clearance (CL) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  9. Part 1: Volume of distribution at steady-state (Vss) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  10. Part 1: Terminal phase elimination rate constant (Lambda z) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  11. Part 1: Terminal phase half-life (T1/2) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  12. Part 1: Percentage extrapolated AUC (%AUCext) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  13. Part 1: Cmax of total monoclonal antibody (mAb) [ Time Frame: Cycle1:predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  14. Part 1: Tmax of total mAb [ Time Frame: Cycle1:predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  15. Part 1: Ctrough of total mAb [ Time Frame: Predose on Cycles 1, 2 and 3 (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  16. Part 1: AUC(0-t) of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  17. Part 1: AUC(0-tau) of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  18. Part 1: AUC(0-infinity) of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  19. Part 1: Tlast of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  20. Part 1: CL of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  21. Part 1: Vss of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  22. Part 1: Lambda z of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  23. Part 1: T1/2 of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  24. Part 1: %AUCext of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  25. Part 1: Cmax of Cys Monomethyl Auristatin F (cys-mcMMAF) [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  26. Part 1: Tmax of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  27. Part 1: Ctrough of cys-mcMMAF [ Time Frame: Predose on Cycles 1 and 3 (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  28. Part 1: AUC(0-168 hours) of cys-mcMMAF [ Time Frame: Predose and up to 168 hours ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  29. Part 1: AUC from zero to time of last quantifiable concentration (AUC[0-tlast]) of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  30. Part 1: AUC(0-tau) of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  31. Part 1: AUC(0-infinity) of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  32. Part 1: %AUCext of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  33. Part 1: Tlast of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  34. Part 1: Lambda z of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  35. Part 1: T1/2 of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  36. Part 2: Cmax of GSK2857916 [ Time Frame: Cycle1:predose,end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  37. Part 2: Tmax of GSK2857916 [ Time Frame: Cycle1:predose,end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  38. Part 2: Ctrough of GSK2857916 [ Time Frame: Predose on Cycles 1, 2 and 3 (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  39. Part 2: AUC(0-t) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  40. Part 2: AUC(0-tau) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  41. Part 2: AUC(0-infinity) of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  42. Part 2: Tlast of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  43. Part 2: CL of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  44. Part 2: Vss of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  45. Part 2: Lambda z of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  46. Part 2: T1/2of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  47. Part 2: %AUCext of GSK2857916 [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  48. Part 2: Cmax of total mAb [ Time Frame: Cycle1:predose,end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  49. Part 2: Tmax of total mAb [ Time Frame: Cycle1:predose,end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle2:predose, EOI & 24 h postdose; Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  50. Part 2: Ctrough of total mAb [ Time Frame: Predose on Cycles 1, 2 and 3 (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  51. Part 2: AUC(0-t) of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  52. Part 2: AUC(0-tau) of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  53. Part 2: AUC(0-infinity) of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  54. Part 2: Tlast of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  55. Part 2: CL of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  56. Part 2: Vss of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  57. Part 2: Lambda z of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  58. Part 2: T1/2 of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  59. Part 2: %AUCext of total mAb [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  60. Part 2: Cmax of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  61. Part 2: Tmax of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  62. Part 2: Ctrough of cys-mcMMAF [ Time Frame: Predose on Cycles 1 and 3 (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  63. Part 2: AUC(0-168 hours) of cys-mcMMAF [ Time Frame: Predose and up to 168 hours ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  64. Part 2: AUC(0-tlast) of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  65. Part 2: AUC(0-tau) of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  66. Part 2: AUC(0-infinity) of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  67. Part 2: %AUCext of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  68. Part 2: Tlast of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  69. Part 2: Lambda z of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  70. Part 2: T1/2 of cys-mcMMAF [ Time Frame: Cycle1: predose, end infusion (EOI), 2, 4, 8,24 hours(h) postdose on Days(D) 4,8,15 & 22(Cycle2 Day1 predose); Cycle3:predose, EOI, 2, 4, 8, 24 h postdose on D 4, 8, 15 & 22(Cycle4 Day1 predose) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.


Secondary Outcome Measures :
  1. Part 1: 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 ]
    Vital signs will be measured after resting for at least 5 minutes.

  2. Part 1: Change from Baseline in Vital Sign- Heart rate (beats per minute) [ Time Frame: Baseline and up to 4 years ]
    Vital signs will be measured after resting for at least 5 minutes.

  3. Part 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 4 years ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  4. Part 1: Number of participants with toxicity grading for hematology parameters [ Time Frame: Up to 4 years ]
    Blood samples will be collected from participants for the analysis of hematology parameters: platelet count, red blood cell count, white blood cell count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  5. Part 1: Number of participants with toxicity grading for clinical chemistry parameters [ Time Frame: Up to 4 years ]
    Blood samples will be collected from participants for the analysis of clinical chemistry parameters: blood urea nitrogen, potassium, aspartate aminotransferase, total and direct bilirubin, creatinine, chloride, alanine aminotransferase, uric acid, glucose (non-fasting), total bicarbonate, gamma glutamyl transferase, albumin, sodium, calcium, alkaline phosphatase, total protein, magnesium, phosphorous, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate and international normalization ratio and prothrombin time.

  6. Part 1: Number of participants with toxicity grading for urine parameters [ Time Frame: Up to 4 years ]
    Urine samples will be collected from participants for the analysis of urinalysis parameters: urine protein and albumin/creatinine ratio.

  7. Part 1: Number of participants with abnormal electrocardiogram findings [ Time Frame: Up to 4 years ]
    Twelve lead electrocardiograms will be obtained using an automated electrocardiogram machine that calculates heart rate and measures PR, QRS, QT and corrected QT intervals according to Fridericia's formula.

  8. Part 1: Number of participants with abnormal physical examination parameters [ Time Frame: Up to 4 years ]
    Physical examination parameters will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities.

  9. Part 2: Change from Baseline in Vital Signs- DBP and SBP (mmHg) [ Time Frame: Baseline and up to 4 years ]
    Vital signs will be measured after resting for at least 5 minutes

  10. Part 2: Change from Baseline in Vital Signs- Heart rate (beats per minute) [ Time Frame: Baseline and up to 4 years ]
    Vital signs will be measured after resting for at least 5 minutes.

  11. Part 2: Number of participants with AEs and SAEs [ Time Frame: Up to 4 years ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  12. Part 2: Number of participants with toxicity grading for hematology parameters [ Time Frame: Up to 4 years ]
    Blood samples will be collected from participants for the analysis of hematology parameters: platelet count, red blood cell count, white blood cell count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils, and basophils.

  13. Part 2: Number of participants with toxicity grading for clinical chemistry parameters [ Time Frame: Up to 4 years ]
    Blood samples will be collected from participants for the analysis of clinical chemistry parameters: blood urea nitrogen, potassium, aspartate aminotransferase, total and direct bilirubin, creatinine, chloride, alanine aminotransferase, uric acid, glucose (non-fasting), total bicarbonate, gamma glutamyl transferase, albumin, sodium, calcium, alkaline phosphatase, total protein, magnesium, phosphorous, creatine kinase, lactate dehydrogenase and estimated glomerular filtration rate, international normalization ratio and prothrombin time.

  14. Part 2: Number of participants with toxicity grading for urine parameters [ Time Frame: Up to 4 years ]
    Urine samples will be collected from participants for the analysis of urinalysis parameters: urine protein and albumin/creatinine ratio.

  15. Part 2: Number of participants with abnormal electrocardiogram findings [ Time Frame: Up to 4 years ]
    Twelve lead electrocardiograms will be obtained using an automated electrocardiogram machine that calculates heart rate and measures PR, QRS, QT and corrected QT intervals according to Fridericia's formula.

  16. Part 2: Number of participants with abnormal physical examination parameters [ Time Frame: Up to 4 years ]
    Physical examination parameters will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
  • Male and/or female must be 18 years of age or older, at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • Participants with histologically or cytologically confirmed diagnosis of multiple myeloma, as defined in International Myeloma Working Group criteria: 1. Has undergone autologous stem cell transplant (SCT) or is considered transplant-ineligible; 2. Has failed at least 2 prior lines of anti-myeloma treatments, including an immunomodulatory drugs (example [e.g.], lenalidomide or pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib).
  • Participants has measurable disease with at least one of the following: Serum M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per liter [g/L]); Urine M-protein >=200 milligram per 24 hours (mg/24 hr); and Serum free light chain assay: Involved free light chain level >=10 milligrams per deciliter (mg/dL) (>=100 milligrams per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or >1.65).
  • Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: 1. Transplant was >100 days prior to study enrollment, 2. No active infection(s), and 3. Participant meets the remainder of the eligibility criteria outlined in this protocol.
  • Participants with adequate organ system functions as defined follows: Absolute neutrophil count >=1.0 x 10^9/liter (L); Hemoglobin >=8.0 g/dL (or 4.9 millimoles per liter); Platelets >= 75 x 10^9/L; Serum bilirubin and aspartate aminotransferase: Group 1 (normal) serum bilirubin and aspartate aminotransferase <=upper limit of normal (ULN); Group 2 (moderate) serum bilirubin >1.5-3 x ULN and any aspartate aminotransferase; alanine aminotransferase <=5 x ULN; Estimated glomerular filtration rate >=30 milliliter per minute per 1.73 meter square (mL/min/m^2); and left ventricular ejection fraction by echocardiograms >=45%.
  • Main additional inclusion criteria in Group 1 (matched control participants): Matched to at least one moderate hepatic impaired participant by Baseline albumin levels (+/-10%) and Baseline weight (+/-20%).
  • Female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 9 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on Cycle 1 Day 1 and agree to use effective contraception during the study and for 9 months after the last dose of study medication. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Male participants: Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following from the time of first dose of study until 6 months after the last dose of study treatment to allow for clearance of any altered sperm, Plus, any of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a WOCBP (including pregnant females).
  • Participants with a history of Hepatitis B virus and/or Hepatitis C virus exposure are eligible under specific conditions.

Exclusion Criteria:

  • Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein and skin changes, Waldenstroem Macroglobulinemia.
  • Participants had a prior allogeneic SCT.
  • Participant has received an investigational drug within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody or prior belantamab mafodotin. The only exception is emergency use of a short course of systemic corticosteroids (equivalent of dexamethasone 40 milligrams per day [mg/day] for a maximum of 4 days) before treatment.
  • Participant has received a strong Organic-anion transporting polypeptide (OATP) inhibitor within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug.
  • Systemic active infection requiring treatment.
  • Any unresolved toxicity >=Grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to Grade 2.
  • Plasmapheresis within 7 days prior to the first dose of study drug. Screening laboratory values must be performed after last plasmapheresis.
  • Any major surgery within the last 4 weeks.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except hepatic impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Evidence of active mucosal or internal bleeding.
  • Current unstable liver or biliary disease per investigator assessment defined by the sudden onset of, or clinically relevant changes in: ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, in the last 14 days prior to the first dose. Participants with cirrhosis are excluded. Participants with focal lesions due to other causes than underlying multiple myeloma are excluded.
  • Participants with acute hepatitis B virus infection are excluded. Participants with chronic hepatitis B infection (active or core antibody positive) are only allowed if the criteria from Organ System Function are fulfilled and if appropriate antiviral treatment per local guidance (e.g. tenofovir or entecavir) is started before starting belantamab mafodotin, continues through to completion of belantamab mafodotin therapy and is not to be stopped unless advised by local hepatology or virology.
  • Participants with evidence of hepatitis C virus infection, defined as positive hepatitis C virus - ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment, are excluded unless successfully treated prior to enrollment with a curative 8-12 week antiviral treatment course and the hepatitis C virus - ribonucleic acid negative status has been confirmed after at least 4 weeks washout of the antiviral treatment.
  • Participants with Gilbert's syndrome.
  • Participants with previous or concurrent malignancies other than multiple myeloma, except: The disease must be considered medically stable for at least 2 years; or the participant must not be receiving active therapy, other than hormonal therapy for this disease.
  • Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz Type II) or third degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; History of severe non-ischemic cardiomyopathy; and Uncontrolled hypertension.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Known human immunodeficiency virus infection.
  • Current corneal epithelial disease except for mild punctuate keratopathy.
  • Participant is a woman who is pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398680


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Florida
GSK Investigational Site
Plantation, Florida, United States, 33322
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jason Eli Tache         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04398680    
Other Study ID Numbers: 209627
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
DREAMM 13
Belantamab mafodotin monotherapy
Hepatic impairment
Normal hepatic function
Relapsed or refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases