A Study to Evaluate the Subcutaneous Belantamab (BCMAb) Formulation Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care

NCT07742527 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 309296
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare how belantamab behaves in the body when given as an injection under the skin (SC) versus into a vein (IV) in participants with multiple myeloma who are receiving standard of care treatment, to enable eventual development of SC formulation. It will assess how much belantamab is absorbed and how long it stays in the blood as well as assess whether it is safe and tolerated well by participants.

Conditions

Multiple Myeloma

Keywords

Belantamab; Monoclonal antibody; B cell Maturation Antigen (BCMA); Subcutaneous belantamab (BCMAb); Intravenous; Subcutaneous; Multiple myeloma; Standard of care; First Line; Second Line; Maintenance; Autologous Stem Cell Transplant (ASCT) Maintenance treatment; DynaMMic; DynaMMic-2

Outcome Measures

Primary Outcomes (7)

• Bioavailability of belantamab

  Up to approximately 42 weeks

• Maximum observed plasma concentration (Cmax) of belantamab

  Up to approximately 42 weeks

• Area under concentration-time curve (AUC) of belantamab

  Up to approximately 42 weeks

• Plasma concentration of belantamab

  Up to approximately 42 weeks

• Number of Participants with Adverse Events (AE)

  Up to approximately 42 weeks

• Number of participants with changes in laboratory parameters

  Up to approximately 42 weeks

• Number of participants with changes in vital signs

  Up to approximately 42 weeks

Secondary Outcomes (2)

• Number of participants with Anti-drug antibodies (ADA) against belantamab

  Up to approximately 71 weeks

• Titers of ADA against belantamab

  Up to approximately 71 weeks

Study Arms (2)

Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1

EXPERIMENTAL

Participants will receive Belantamab subcutaneous (SC) dose level 1 (DL1) +Recombinant Human Hyaluronidase PH20 (rHuPH20) in Period 1; followed by Belantamab intravenous (IV) DL1 in Period 2; followed by Belantamab SC DL2 + rHuPH20 in Period 3; further followed by Belantamab SC DL1 + rHuPH20 in Period 4. Dose level 1 is the lowest dose level.

Drug: Belantamab SC; Drug: Belantamab IV; Drug: Recombinant Human Hyaluronidase PH20 (rHuPH20); Drug: Standard of care

Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1

EXPERIMENTAL

Participants will receive Belantamab IV DL1 in Period 1; followed by Belantamab SC DL1 + rHuPH20 in Period 2; followed by Belantamab SC DL2 + rHuPH20 in Period 3; further followed by Belantamab SC DL1 + rHuPH20 in Period 4 of the study. Dose level 1 is the lowest dose level.

Drug: Belantamab SC; Drug: Belantamab IV; Drug: Recombinant Human Hyaluronidase PH20 (rHuPH20); Drug: Standard of care

Interventions

Belantamab SC DRUG

Belantamab will be administered via SC route.

Also known as: GSK2857914

Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1; Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1

Belantamab IV DRUG

Belantamab will be administered via IV route.

Also known as: GSK2857914

Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1; Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1

Recombinant Human Hyaluronidase PH20 (rHuPH20) DRUG

rHuPH20 will be administered via SC route.

Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1; Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1

Standard of care DRUG

Participants will receive standard of care: Lenalidomide and/or anti-CD38 mAb as maintenance therapy.

Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1; Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participants at the time of signing the Informed Consent Form (ICF) must be aged 18 years old or greater or are of the legal age of consent in the jurisdiction in which the study is taking place.
• Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined by the International Myeloma Working Group (IMWG).
• Currently receiving maintenance therapy with either anti- cluster of differentiation 38 (anti-CD38) directed therapy, or lenalidomide, or both, following autologous stem cell transplantation (ASCT) in either first or second line.
• No change in current myeloma treatment for at least 2 months prior to during screening, or during the trial.
• Partial response (PR) or better per IMWG per Investigator's assessment for at least 2 months prior to screening.
• All current treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version (v) 6.0, 2025) must be Grade less than or equal to (\<=) 2 at the time of screening except for alopecia (any grade), or endocrinopathy managed with replacement therapy (any grade).
• ASCT must be greater than (\>) 100 days prior to screening, and participants are transfusion independent and not receiving granulocyte colony-stimulating factor (G-CSF) or thrombopoietin analogies.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have organ system functions as defined by the laboratory assessments.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, and skin changes (POEMS) syndrome, primary plasma cell leukemia, or non-secretory myeloma.
• Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
• Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab, or hyaluronidase, or any of the components of the study treatment. History of severe hypersensitivity to other monoclonal antibodies (mAbs).
• Active infection requiring antibiotic, antiviral, or antifungal treatment.
• Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety).
• Prior B cell maturation antigen (BCMA) directed therapy.
• Plasmapheresis within 7 days prior to the first dose of study drug.
• Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.
• Participants must not receive live/live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab for at least 70 days following last study treatment.
• Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type within 60 days of an investigational medicinal product before randomization.
• Known human immunodeficiency virus (HIV) infection, unless the participant can meet all the following criteria:
• Established antiretroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/milliliter (mL)
• CD4+ T-cell (CD4+) counts greater than or equal to (\>=) 350 cells/microliter (uL)

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): March 18, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share