A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

Last updated: June 4, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Cancer/tumors

Bone Neoplasm

Treatment

Belamaf

Bela

Belantamab

Clinical Study ID

NCT05714839
218670
2022-501941-63-00
2022-501941-63
  • Ages > 18
  • All Genders

Study Summary

The study consists of two parts: Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with belantamab (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants at the time of signing the Informed Consent Form (ICF) are at least 18years old or are of the legal age of consent in the jurisdiction in which the studyis taking place.

  • Participants who have histologically or cytologically confirmed diagnosis ofMultiple Myeloma (MM), as defined by the international myeloma working group (IMWG).

  1. Participants who have received at least 3 prior lines of anti-myelomatreatments, and have already received an immunomodulating agent, a proteasomeinhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable) andhave confirmed progression on or following the last line of treatment.
  • Participants with a history of Autologous stem cell transplant (ASCT) are eligiblefor study participation provided the following eligibility criteria are met:
  1. transplant was greater than (>)100 days prior to screening.

  2. no active infection(s)

  • Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.

  • Measurable disease defined as at least ONE of the following:

  1. Serum M-protein concentration greater than (>=) 0.5 gram (g)/ deciliter (dL) (>=5 gram/liter [g/L])

  2. Urine M-protein excretion >=200 mg/24 hours (>=0.2 g/24 hours)

  3. Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100milligrams per liter [mg/L]) and an abnormal serum FLC ratio (less than [<]0.26or >1.65)

  • Have adequate organ system function as defined by the laboratory assessments.

  • All prior treatment-related toxicities (defined by National Cancer Institute-CommonToxicity Criteria for Adverse Events [NCI-CTCAE], v5.0, 2017) must be Grade <=1 atthe time of screening except for alopecia (any grade), neuropathy (Grade <=2), orendocrinopathy managed with replacement therapy (any grade).

  • Participants or Legally authorized representative (LAR) capable of giving signedinformed consent, which includes compliance with the requirements and restrictionslisted in the ICF and in this protocol.

Exclusion

Exclusion Criteria:

  • Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy,organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome,primary plasma cell leukemia.

  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or otherconditions (including lab abnormalities) that could interfere with participant'ssafety, obtaining informed consent, or compliance with study procedures.

  • Participant is exhibiting signs of meningeal or central nervous system involvementwith MM.

  • Current corneal epithelial disease except nonconfluent Superficial punctatekeratitis (SPK).

  • Has cirrhosis or current unstable liver or biliary disease per investigatorassessment defined by the presence of ascites, encephalopathy, coagulopathy,hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.

  • Presence of malignancies other than disease under study are excluded, except for anyother malignancy from which the participant has been disease-free for more than 2years and, in the opinion of the Principal investigator (PI) and GlaxoSmithKline (GSK) Medical Director, will not affect the evaluation of the effects of thisclinical trial treatment on the currently targeted malignancy (MM).

  • Evidence of cardiovascular risk

  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugschemically related to belantamab / belantamab mafodotin or any of the components ofthe study treatment. History of severe hypersensitivity to other Monoclonalantibodies (mAbs).

  • Active infection requiring antibiotic, antiviral, or antifungal treatment.

  • Known Human immunodeficiency virus (HIV) infection, unless the participant can meetspecific criteria.

  • Recent history (within the past 6 months) of acute diverticulitis, inflammatorybowel disease, intra-abdominal abscess, or gastrointestinal obstruction.

  • Participants with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will beexcluded unless specific criteria can be met

  • Presence of active renal condition (infection, requirement for dialysis or any othercondition that could affect participant's safety). Participants with isolatedproteinuria resulting from MM are eligible

  • Part 1: Refractory to belantamab mafodotin (confirmed PD as per IMWG criteria whileon belantamab mafodotin therapy or within 60 days of completing that treatment).Prior belantamab mafodotin is allowed if it was discontinued due to toxicity whichsubsequently resolved.

  • Part 2: Prior belantamab mafodotin therapy is not allowed. Prior treatment withother anti-BCMA directed agents is allowed provided there is at least a 6-monthwashout period from completion of prior anti-BCMA therapy to start of study therapy.

  • Prior radiotherapy within 2 weeks of start of study therapy.

  • Plasmapheresis within 7 days prior to the first dose of study drug.

  • Prior allogeneic transplant is prohibited.

  • Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.

  • Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first doseor has not recovered fully from surgery.

  • Prior treatment with a mAb within 30 days of receiving the first dose of studydrugs, or treatment with an investigational agent or approved systemic anti-myelomatherapy (including systemic steroids) within 14 days or 5 half-lives of receivingthe first dose of study drugs, whichever is longer.

  • Part 1: Has received transfusion of blood products (including platelets or red bloodcells) or administration of colony stimulating factors (including Granulocyte colonystimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GMCSF), recombinant erythropoietin) or any thrombopoietin receptor agonists within 2 weeks before the first dose of study drug.

  • Participants must not receive live/live attenuated vaccines within 30 days prior tofirst dose of study treatment or whilst receiving belantamab for at least 70 daysfollowing last study treatment.

  • Known, current drug or alcohol abuse.

  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling,or child) who is investigational site or Sponsor staff directly involved with thistrial, unless prospective Independent Review Board (IRB) approval (by chair ordesignee) is allowing exception to this criterion for a specific participant.

Study Design

Total Participants: 55
Treatment Group(s): 8
Primary Treatment: Belamaf
Phase: 1
Study Start date:
June 14, 2023
Estimated Completion Date:
December 03, 2029

Connect with a study center

  • GSK Investigational Site

    Ciudadela, B1702
    Argentina

    Completed

  • GSK Investigational Site

    Viedma, R8500ACE
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Nedlands, Western Australia 6009
    Australia

    Completed

  • GSK Investigational Site

    Joinville, 89201-260
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    SAo Paulo, 04537-080
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Salvador, 41253-190
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    São Paulo, 04537-080
    Brazil

    Site Not Available

  • GSK Investigational Site

    Aomori, 030-8553
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Osaka, 545-8586
    Japan

    Completed

  • GSK Investigational Site

    Tokyo, 105-8471
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 137-701
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seoul, Korea, 137-701
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Mexico City, 01330
    Mexico

    Site Not Available

  • GSK Investigational Site

    Gdansk, 80-214
    Poland

    Site Not Available

  • GSK Investigational Site

    Lublin, 20-081
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Changhua, 500
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Taipei, 100
    Taiwan

    Active - Recruiting

  • GSK Investigational Site

    Istanbul, 34010
    Turkey

    Site Not Available

  • GSK Investigational Site

    Kayseri, 38039
    Turkey

    Site Not Available

  • GSK Investigational Site

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Oxford., OX3 7LE
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

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