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A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function (DREAMM 13)

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 : Recruiting
First Posted : May 21, 2020
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

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 ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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)
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : November 28, 2025
Estimated Study Completion Date : November 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Belantamab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1, Group 1: Participants with normal hepatic function
Participants with normal hepatic function (Serum bilirubin and Aspartate aminotransferase [AST] less than or equal to [<=] Upper limit of normal [ULN]) will be administered with Belantamab mafodotin
 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered
Experimental: Part 1, Group 2: Participants with moderate hepatic impairment
Participants with moderate hepatic impairment (Serum bilirubin greater than >1.5 - 3 times ULN and any AST) will be administered with Belantamab mafodotin
 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered
Experimental: Part 2,Group 3: Participants with severe hepatic impairment
Participants with severe hepatic impairment (Serum bilirubin >3 times ULN and any AST) will be administered with Belantamab mafodotin
 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of GSK2857916 [ Time Frame: Up to 48 months ]
  2. Part 1 and Part 2: Time to Cmax (Tmax) of GSK2857916 [ Time Frame: Up to 48 months ]
  3. Part 1 and Part 2: Concentration at the end of infusion (C-EOI) [ Time Frame: Up to 48 months ]
  4. Part 1 and Part 2: Predose plasma concentration (Ctrough) of GSK2857916 [ Time Frame: Up to 48 months ]
  5. 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 ]
  6. Part 1 and Part 2 : AUC over the dosing interval (AUC[0-tau]) of GSK2857916 [ Time Frame: Up to 48 months ]
  7. Part 1 and Part 2: Last time point where the concentration is above the limit of quantification (Tlast) of GSK2857916 [ Time Frame: Up to 48 months ]
  8. Part 1 and Part 2: Cmax of total monoclonal antibody (mAb) [ Time Frame: Up to 48 months ]
  9. Part 1 and Part 2: Tmax of total mAb [ Time Frame: Up to 48 months ]
  10. Part 1 and Part 2: C-EOI of total mAB [ Time Frame: Up to 48 months ]
  11. Part 1 and Part 2: Ctrough of total mAb [ Time Frame: Up to 48 months ]
  12. 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 ]
  13. Part 1 and Part 2: AUC(0-tau) of total mAb [ Time Frame: Up to 48 months ]
  14. Part 1 and Part 2: Tlast of total mAb [ Time Frame: Up to 48 months ]
  15. Part 1 and Part 2: Cmax of Cys Monomethyl Auristatin F (cys-mcMMAF) [ Time Frame: Up to 48 months ]
  16. Part 1 and Part 2: Tmax of cys-mcMMAF [ Time Frame: Up to 48 months ]
  17. Part 1 and Part 2: C-EOI of cys-mcMMAF [ Time Frame: Up to 48 months ]
  18. Part 1 and Part 2: AUC(0-168 hours) of cys-mcMMAF [ Time Frame: Up to 48 months ]
  19. Part 1 and Part 2: tlast of cys-mcMMAF [ Time Frame: Up to 48 months ]

Secondary Outcome Measures :
  1. 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 ]
  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 ]
  3. Part 1 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 4 years ]
  4. Part 1 and Part 2: Number of participants with toxicity grading for hematology parameters [ Time Frame: Up to 4 years ]
  5. Part 1 and Part 2: Number of participants with toxicity grading for clinical chemistry parameters [ Time Frame: Up to 4 years ]
  6. Part 1 and Part 2: Number of participants with toxicity grading for urine parameters [ Time Frame: Up to 4 years ]
  7. 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.


Eligibility Criteria
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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 greater than or equal to (>=)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 times 10^9/liter (L); Hemoglobin >=8.0 g/dL (or 4.9 millimoles per liter); Platelets >= 75 times 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 times ULN and any aspartate aminotransferase; alanine aminotransferase <=5 ULN; Estimated glomerular filtration rate >=60 milliliter per minute per 1.73 meter square (mL/min/m^2); Urine dipstick for protein or Albumin/creatinine ratio (from spot urine) negative/trace (if >=1+ only eligible if confirmed <=500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void; and left ventricular ejection fraction by echocardiograms >=45 percent (%).
  • 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).
  • 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.
  • 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.
  • Prior belantamab mafodotin therapy
  • Systemic active infection requiring treatment
  • Any unresolved toxicity >=Grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to Grade 2.
  • 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.
  • 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.
  • 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 human immunodeficiency virus infection.
  • Current corneal epithelial disease except for mild punctuate keratopathy.
  • Participant is a woman who is pregnant or breastfeeding.
Contacts and Locations
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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, Arizona
GSK Investigational Site Recruiting
Tucson, Arizona, United States, 85724
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: Krisstina Gowin         
United States, California
GSK Investigational Site Recruiting
Beverly Hills, California, United States, 90211
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: Eli Gabayan         
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, Illinois
GSK Investigational Site Recruiting
Chicago, Illinois, United States, 60611
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: Seema Singhal         
United States, Kansas
GSK Investigational Site Recruiting
Wichita, Kansas, United States, 67214
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: Shaker R Dakhil         
United States, Maryland
GSK Investigational Site Recruiting
Baltimore, Maryland, United States, 21201-1595
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: Mehmet Hakan Kocoglu         
United States, New Jersey
GSK Investigational Site Recruiting
Hackensack, New Jersey, United States, 07601
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: David Vesole         
United States, Pennsylvania
GSK Investigational Site Recruiting
Monroeville, Pennsylvania, United States, 15146
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: Kathleen Dorritie         
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         
United States, Wisconsin
GSK Investigational Site Recruiting
Milwaukee, Wisconsin, United States, 53233
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: Michael A Thompson         
Greece
GSK Investigational Site Recruiting
Athens, Greece, 10676
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: Sosana Delimpasi         
GSK Investigational Site Recruiting
Athens, Greece, 11528
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: Meletios Athanasios Dimopoulos         
Korea, Republic of
GSK Investigational Site Recruiting
Busan, Korea, Republic of, 49201
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: Sung-Hyun Kim         
GSK Investigational Site Recruiting
Busan, Korea, Republic of, 49241
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: Ho-Jin Shin         
GSK Investigational Site Recruiting
Daegu, Korea, Republic of, 41944
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: Sang Kyun Sohn         
GSK Investigational Site Recruiting
Hwasun, Korea, Republic of, 58128
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: Je-Jung Lee         
GSK Investigational Site Recruiting
Incheon, Korea, Republic of, 405-760
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: Jae Hoon Lee         
GSK Investigational Site Recruiting
Jeonju-si, Korea, Republic of, 561-172
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: Ho-Young Yhim         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03080
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: Youngil Koh         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 06591
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: Chang Ki Min         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 120-752
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: Jin Seok Kim         
GSK Investigational Site Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
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: Yoon Seok Choi         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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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: November 30, 2022
Last Verified: November 2022
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 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