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Multiple MyelomaPhase 1DREAMM 13NCT04398680

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

A Phase 1 study testing Belantamab mafodotin in people with Multiple Myeloma, run by GlaxoSmithKline at 18 sites in 3 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Belantamab mafodotin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
18 sitesin 3 countries
Study dates
20 Apr 2021to 4 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

South Korea9 sites

  • GSK Investigational Site

    Daegu, 41944

  • GSK Investigational Site

    Hwasun, 58128

  • GSK Investigational Site

    Incheon, 405-760

  • GSK Investigational Site

    Jeonju, 561-172

  • GSK Investigational Site

    Pusan, 49241

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Suwon Kyunggi-do, 16499

Other trials in South Korea

United States8 sites

  • GSK Investigational Site

    Baltimore, Maryland, 21201-1595

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53233

  • GSK Investigational Site

    Monroeville, Pennsylvania, 15146

  • GSK Investigational Site

    Plantation, Florida, 33322

  • GSK Investigational Site

    The Woodlands, Texas, 77380

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Wichita, Kansas, 67214

Other trials in United States

Greece1 site

  • GSK Investigational Site

    Athens, 10676

Other trials in Greece

About this study

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)

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.

Being tested
Belantamab mafodotin
Keywords
DREAMM 13, Belantamab mafodotin monotherapy, Hepatic impairment, Normal hepatic function, Relapsed or refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belantamab mafodotinDrug

    Belantamab mafodotin will be administered

Study groups in NCT04398680
Study groupRoleWhat they receive
Part 1, Group 1: Participants with normal hepatic functionExperimentalParticipants 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
Receives: Drug: Belantamab mafodotin
Part 1, Group 2: Participants with moderate hepatic impairmentExperimentalParticipants with moderate hepatic impairment (Serum bilirubin greater than >1.5 - 3 times ULN and any AST) will be administered with Belantamab mafodotin
Receives: Drug: Belantamab mafodotin
Part 2,Group 3: Participants with severe hepatic impairmentExperimentalParticipants with severe hepatic impairment (Serum bilirubin >3 times ULN and any AST) will be administered with Belantamab mafodotin
Receives: Drug: Belantamab mafodotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of Belantamab Mafodotin

    Measured: Up to 48 months

  2. Part 1 and Part 2: Time to Cmax (Tmax) of Belantamab Mafodotin

    Measured: Up to 48 months

  3. Part 1 and Part 2: Concentration at the end of infusion (C-EOI)

    Measured: Up to 48 months

  4. Part 1 and Part 2: Predose plasma concentration (Ctrough) of Belantamab Mafodotin

    Measured: 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)

    Measured: Up to 48 months

  6. Part 1 and Part 2: Last time point where the concentration is above the limit of quantification (Tlast) of Belantamab Mafodotin

    Measured: Up to 48 months

  7. Part 1 and Part 2: Cmax of total monoclonal antibody (mAb)

    Measured: Up to 48 months

  8. Part 1 and Part 2: Tmax of total mAb

    Measured: Up to 48 months

  9. Part 1 and Part 2: C-EOI of total mAB

    Measured: Up to 48 months

  10. Part 1 and Part 2: Ctrough of total mAb

    Measured: Up to 48 months

  11. Part 1 and Part 2: Area under the plasma concentration-time curve (from zero to the end of dosing interval)of total mAb

    Measured: Up to 48 months

  12. Part 1 and Part 2: Tlast of total mAb

    Measured: Up to 48 months

  13. Part 1 and Part 2: Cmax of Cys Monomethyl Auristatin F (cys-mcMMAF)

    Measured: Up to 48 months

  14. Part 1 and Part 2: Tmax of cys-mcMMAF

    Measured: Up to 48 months

  15. Part 1 and Part 2: C-EOI of cys-mcMMAF

    Measured: Up to 48 months

  16. Part 1 and Part 2: AUC(0-168 hours) of cys-mcMMAF

    Measured: Up to 48 months

  17. Part 1 and Part 2: tlast of cys-mcMMAF

    Measured: Up to 48 months

Secondary outcomes (6)

  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])

    Measured: Baseline and up to 4 years

  2. Part 1 and Part 2: Change from Baseline in Vital Sign- Heart rate (beats per minute)

    Measured: Baseline and up to 4 years

  3. Part 1 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Measured: Up to 4 years

  4. Part 1 and Part 2: Number of participants with toxicity grading for hematology parameters

    Measured: Up to 4 years

  5. Part 1 and Part 2: Number of participants with toxicity grading for clinical chemistry parameters

    Measured: Up to 4 years

  6. Part 1 and Part 2: Number of participants with toxicity grading for urine parameters

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start20 Apr 2021
  3. Primary completion4 Nov 2025 (estimated)
  4. Study completion4 Nov 2025 (estimated)

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398680
Sponsor's protocol ID
209627
Acronym
DREAMM 13
Status last verified
Nov 2025
First submitted
19 May 2020
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Belantamab mafodotin in people with Multiple Myeloma, run by GlaxoSmithKline at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in South Korea, United States, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of Belantamab Mafodotin (time frame: Up to 48 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04398680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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