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A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function (DREAMM 12)

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: NCT04398745
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : October 22, 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). 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.

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 : 36 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 and/or Refractory Multiple Myeloma (RRMM) Who Have Normal and Varying Degrees of Impaired Renal Function (DREAMM 12)
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : March 7, 2025
Estimated Study Completion Date : March 7, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: Participants with normal/mild impaired renal function
Participants with normal or mildly impaired renal function (Normal: estimated glomerular filtration rate [eGFR]: >=90 milliliter per minute per 1.73 meter square [mL/min/1.73 m^2]; Mild impairment: eGFR: 60-89 mL/min/1.73 m^2) will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W 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 normal 0.9 % saline before use.

Experimental: Part 1: Participants with severe renal impairment
Participants with severely impaired renal function (eGFR: 15-29 mL/min/1.73 m^2) will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W 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 normal 0.9 % saline before use.

Experimental: Part 2: Participants with ESRD (not on dialysis)

Participants with ESRD (eGFR:

<15 mL/min/1.73 m^2) not on dialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W 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 normal 0.9 % saline before use.

Experimental: Part 2: Participants with ESRD (on hemodialysis)
Participants with ESRD (eGFR: <15 mL/min/1.73 m^2) on hemodialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W 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 normal 0.9 % 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: Concentration of GSK2857916 at the end of infusion (C-EOI) [ Time Frame: Cycle 1 up to Cycle 3: end infusion (EOI) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  4. Part 1: Predose plasma concentration (Ctrough) of GSK2857916 [ Time Frame: Predose on Cycle 1 and up to Cycle 3 (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: 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.

  7. 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.

  8. 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.

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

  10. Part 1: C-EOI of mAb [ Time Frame: Cycle 1 up to Cycle 3: end infusion (EOI) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Part 1: C-EOI of cys-mcMMAF [ Time Frame: Cycle 1 up to Cycle 3: end infusion (EOI) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Part 2: C-EOI of GSK2857916 [ Time Frame: Cycle 1 up to Cycle 3: end infusion (EOI) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

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

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. Part 2: C-EOI of mAb [ Time Frame: Cycle 1 up to Cycle 3: end infusion (EOI) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

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

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. Part 2: C-EOI of cys-mcMMAF [ Time Frame: Cycle 1 up to Cycle 3: end infusion (EOI) (each cycle is 21 days) ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  33. 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.

  34. 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.

  35. Part 2: AUC from start of dialysis (t0) to end of dialysis (t1) (AUC[t0-t1]) in ESRD - hemodialysis group [ Time Frame: Up to Day 4 ]
    Partial area under the curve estimated from predialyzer samples collected from start of dialysis (t0) to end of dialysis (t1). Dialysate samples will be collected at indicated time points.

  36. Part 2: Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) from start of dialysis (t0) to end of dialysis (t1) in ESRD - hemodialysis group [ Time Frame: Up to Day 4 ]
    Arem is defined as the total amount of drug removed by hemodialysis at indicated time points. Dialysate samples will be collected at indicated time points.

  37. Part 2: Dialysis Clearance (CLD) in ESRD - hemodialysis group [ Time Frame: Up to Day 4 ]
    Dialysis clearance, calculated as Arem(t0-t1) divided by AUC(t0-t1). Dialysate samples will be collected at indicated time points.

  38. Part 2: Fraction (%) of the dose removed by hemodialysis from start of dialysis (t0) to end of dialysis (t1) (Frem%[0-t1]) in ESRD - hemodialysis group%[0-t1]) of ESRD - hemodialysis group [ Time Frame: Up to Day 4 ]
    Frem is defined as the fraction (dose in percentage) removed by the process of hemodialysis from t0 to t1 of hemodialysis. Dialysate samples will be collected at indicated time points.


Secondary Outcome Measures :
  1. Part 1 and Part 2: Change from Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (millimeter 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 and Part 2: 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 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 4 years ]
    AEs and SAEs will be collected at specified time points.

  4. Part 1 and Part 2: Number of participants with toxicity grading for hematology and clinical chemistry parameters [ Time Frame: Up to 4 years ]
    Blood samples will be collected from participants for the analysis of toxicity grading for hematology, and clinical chemistry parameters

  5. Part 1 and Part 2: Number of participants with toxicity grading for urinalysis parameters [ Time Frame: Up to 4 years ]
    Urine samples will be collected from participants for the analysis of toxicity grading for urinalysis parameters.

  6. Part 1 and 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.


Layout table for eligibility information
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 participants must be 18 years of age or older, at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Participants with histologically or cytologically confirmed diagnosis of MM, 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 milligrams (mg) per 24 hours (mg/24 h); and Serum free light chain (FLC) assay: Involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligrams per liter [mg/L]) and an abnormal serum FLC 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 per liter (/L); Hemoglobin >=7.0 g/dL or 4.9 millimoles per liter (mmol/L); Platelets >= 50 x 10^9/L; Total bilirubin <=1.5 x Upper limit of normal (ULN) (Isolated bilirubin >=1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]); Alanine aminotransferase <=2.5 x ULN; eGFR, Group 1: normal/ mild impairment >=60milliliter per minute per 1.73 meter square (mL/min/1.73m^2); Group 2: severe 15-29 mL/min/1.73 m^2; Group 3: ESRD (not on dialysis) <15 mL/min/1.73 m^2; Group 4: ESRD (on dialysis) <15 mL/min/1.73 m^2; and left ventricular ejection fraction by echocardiograms >=40%.
  • Main additional inclusion criteria in Group 1 (matched control participants): Matched to at least one severely renal impaired participant by Baseline body weight (+/-20%) and Baseline albumin levels (+/-10%).
  • 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 at least one of the following conditions applies: Is 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 4 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 highly effective contraception during the study and for 4 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: Refrain from donating sperm and either; 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).

Exclusion Criteria:

  • Participants with active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein and skin changes), Waldenstroem Macroglobulinemia
  • Participants had a prior allogeneic stem cell transplant.
  • 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. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 milligrams per day [mg/day] for a maximum of 4 days) before treatment.
  • Prior belantamab mafodotin therapy.
  • Participant has received a strong Organic-anion transporting polypeptide 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 prior to Day 1 of Screening.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal 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 presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • Participants with previous or concurrent malignancies other than MM are excluded, unless the prior malignancy has been considered medically stable for at least 2 years. 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 such as second degree (Mobitz Type II) or third degree atrioventricular block; History of myocardial infarction (within prior 18 months), 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.
  • 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.
  • Presence of hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (anti-HbcAb), at Screening or within 3 months prior to first dose of study treatment.
  • Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid test result at Screening or within 3 months prior to first dose of study treatment.
  • Participants with renal impairment due to hepatic disease (hepatorenal syndrome).
  • 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): NCT04398745


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 Recruiting
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         
United States, Texas
GSK Investigational Site Recruiting
The Woodlands, Texas, United States, 77380
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: Mary Kuntz Crow         
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: NCT04398745    
Other Study ID Numbers: 209626
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: October 22, 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, key secondary endpoints and safety data 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 12
End-stage renal disease
Normal renal function
Renal impairment
Relapsed and/or refractory multiple myeloma
Belantamab mafodotin
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
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
Kidney Diseases
Urologic Diseases