A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function (DREAMM 13)
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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Phase
Phase
- Phase 1
Expanded Access
Expanded Access
Available
- Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
- No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
- Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
- Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Contacts and Locations
Study Contact
Study Contact
- Name: US GSK Clinical Trials Call Center
- Phone Number: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Study Contact Backup
- Name: EU GSK Clinical Trials Call Center
- Phone Number: +44 (0) 20 89904466
- Email: GSKClinicalSupportHD@gsk.com
Study Locations
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Athens, Greece, 10676
- GSK Investigational Site
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Daegu, South Korea, 41944
- GSK Investigational Site
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Hwasun, South Korea, 58128
- GSK Investigational Site
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Incheon, South Korea, 405-760
- GSK Investigational Site
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Jeonju, South Korea, 561-172
- GSK Investigational Site
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Pusan, South Korea, 49241
- GSK Investigational Site
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Seoul, South Korea, 03080
- GSK Investigational Site
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Seoul, South Korea, 06591
- GSK Investigational Site
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Seoul, South Korea, 120-752
- GSK Investigational Site
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Suwon Kyunggi-do, South Korea, 16499
- GSK Investigational Site
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Arizona
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Tucson, Arizona, United States, 85724
- GSK Investigational Site
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California
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Beverly Hills, California, United States, 90211
- GSK Investigational Site
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Florida
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Plantation, Florida, United States, 33322
- GSK Investigational Site
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Kansas
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Wichita, Kansas, United States, 67214
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21201-1595
- GSK Investigational Site
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Pennsylvania
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Monroeville, Pennsylvania, United States, 15146
- GSK Investigational Site
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Texas
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The Woodlands, Texas, United States, 77380
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53233
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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: Has failed at least 1 prior line of anti-myeloma
- 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]); abnormal serum free light chain ratio (<0.26 or >1.65); participants with plasmacytoma and otherwise non-measurable disease
- 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 below: 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 >=30 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 and HIV 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 if given within the last 90 days.
- 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 Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undetectable at the time of screening; If HbsAg+ at screening or <=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment. Participants with cirrhosis are excluded.
- 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 unless the participant can meet the following criteria: RNA test negative and/or Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks prior to first dose.
- Participants with Gilbert's syndrome.
- -Participants with previous or concurrent invasive malignancies other than MM are excluded, unless the prior malignancy has been considered medically stable for at least 1 year. 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; and Uncontrolled hypertension.
- Known human immunodeficiency virus infection, unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/mL prior to first dose; CD4+ T-cell (CD4+) counts ≥350 cells/ L and no history of AIDS-defining opportunistic infections within the last 12 months.
- Current corneal epithelial disease except for mild punctuate keratopathy.
- Participant is a woman who is pregnant or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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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
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Belantamab mafodotin will be administered
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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
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Belantamab mafodotin will be administered
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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
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Belantamab mafodotin will be administered
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Part 1 and Part 2: Concentration at the end of infusion (C-EOI)
Time Frame: Up to 48 months
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Up to 48 months
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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
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Up to 48 months
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Part 1 and Part 2: Cmax of total monoclonal antibody (mAb)
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Tmax of total mAb
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: C-EOI of total mAB
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Ctrough of total mAb
Time Frame: Up to 48 months
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Up to 48 months
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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
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Up to 48 months
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Part 1 and Part 2: Tlast of total mAb
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Cmax of Cys Monomethyl Auristatin F (cys-mcMMAF)
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Tmax of cys-mcMMAF
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: C-EOI of cys-mcMMAF
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: AUC(0-168 hours) of cys-mcMMAF
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: tlast of cys-mcMMAF
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of Belantamab Mafodotin
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Time to Cmax (Tmax) of Belantamab Mafodotin
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Predose plasma concentration (Ctrough) of Belantamab Mafodotin
Time Frame: Up to 48 months
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Up to 48 months
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Part 1 and Part 2: Last time point where the concentration is above the limit of quantification (Tlast) of Belantamab Mafodotin
Time Frame: Up to 48 months
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Up to 48 months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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Baseline and up to 4 years
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Part 1 and Part 2: Change from Baseline in Vital Sign- Heart rate (beats per minute)
Time Frame: Baseline and up to 4 years
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Baseline and up to 4 years
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Part 1 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 4 years
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Up to 4 years
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Part 1 and Part 2: Number of participants with toxicity grading for hematology parameters
Time Frame: Up to 4 years
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Up to 4 years
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Part 1 and Part 2: Number of participants with toxicity grading for clinical chemistry parameters
Time Frame: Up to 4 years
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Up to 4 years
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Part 1 and Part 2: Number of participants with toxicity grading for urine parameters
Time Frame: Up to 4 years
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Up to 4 years
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neoplasms
- Disease Attributes
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Recurrence
- Multiple Myeloma
- belantamab mafodotin
Other Study ID Numbers
Other Study ID Numbers
- 209627
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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