A Study to Evaluate the Subcutaneous Belantamab (BCMAb) Formulation Versus Intravenous Belantamab… (NCT07742527) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Subcutaneous Belantamab (BCMAb) Formulation Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care
22 participantsStarted 2026-10-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) perform…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bioavailability of belantamab
Timeframe: Up to approximately 42 weeks
2
Maximum observed plasma concentration (Cmax) of belantamab
Timeframe: Up to approximately 42 weeks
3
Area under concentration-time curve (AUC) of belantamab
Timeframe: Up to approximately 42 weeks
4
Plasma concentration of belantamab
Timeframe: Up to approximately 42 weeks
5
Number of Participants with Adverse Events (AE)
Timeframe: Up to approximately 42 weeks
6
Number of participants with changes in laboratory parameters
Timeframe: Up to approximately 42 weeks
7
Number of participants with changes in vital signs