Can a simple injection replace an IV for this myeloma drug?
NCT ID NCT07742527
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial is testing whether belantamab, a drug used for multiple myeloma, can be given as a quick injection under the skin instead of a slow drip into a vein. About 22 adults with multiple myeloma who are already on standard maintenance therapy will receive both forms in a crossover design, allowing direct comparison. The study measures how much of the drug reaches the blood, how long it stays there, and whether the injection is safe and well tolerated. If successful, this could make treatment more convenient without compromising effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belantamab (an antibody-drug conjugate) given as a subcutaneous injection with recombinant human hyaluronidase PH20, compared with intravenous belantamab
- What this could lead to
- If the subcutaneous version works as well as the intravenous one, it could offer a more convenient way to deliver belantamab for multiple myeloma patients, potentially reducing clinic visits and improving comfort.
- What could go wrong
- This is an early-phase trial with only 22 participants, so results may not apply broadly. The subcutaneous formulation might not match the intravenous version in absorption or safety, and side effects could still emerge.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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) * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months * Participants with hepatitis B virus (HBV) infection will be excluded * Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) 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 * Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks. * Is pregnant or breastfeeding. * Evidence of cardiovascular risk including any of the following: * Evidence of current clinically significant untreated arrhythmias, including, but not limited to, clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. * History of myocardial infarction (MI), acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of screening. * Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. * Uncontrolled hypertension.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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