Multiple MyelomaPhase 1DynaMMic-2NCT07742527
A Study to Evaluate the Subcutaneous Belantamab (BCMAb) Formulation Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care
A Phase 1 study testing Belantamab SC, Belantamab IV and Recombinant Human Hyaluronidase PH20 (rHuPH20) in people with Multiple Myeloma, run by GlaxoSmithKline.
Trial 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. 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 SC, Belantamab IV and Recombinant Human Hyaluronidase PH20 (rHuPH20)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2026to 18 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Phase 1b, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Subcutaneous Belantamab (BCMAb) Formulation With rHuPH20 Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care
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
- Being tested
- Belantamab SC, Belantamab IV, Recombinant Human Hyaluronidase PH20 (rHuPH20), Standard of care
- 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
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belantamab SCDrug
Also called GSK2857914
Belantamab will be administered via SC route.
Belantamab IVDrug
Also called GSK2857914
Belantamab will be administered via IV route.
Recombinant Human Hyaluronidase PH20 (rHuPH20)Drug
rHuPH20 will be administered via SC route.
Standard of careDrug
Participants will receive standard of care: Lenalidomide and/or anti-CD38 mAb as maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Belantamab SC; Drug: Belantamab IV; Drug: Recombinant Human Hyaluronidase PH20 (rHuPH20); Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of belantamab
Measured: Up to approximately 42 weeks
Maximum observed plasma concentration (Cmax) of belantamab
Measured: Up to approximately 42 weeks
Area under concentration-time curve (AUC) of belantamab
Measured: Up to approximately 42 weeks
Plasma concentration of belantamab
Measured: Up to approximately 42 weeks
Number of Participants with Adverse Events (AE)
Measured: Up to approximately 42 weeks
Number of participants with changes in laboratory parameters
Measured: Up to approximately 42 weeks
Number of participants with changes in vital signs
Measured: Up to approximately 42 weeks
Secondary outcomes (2)
Number of participants with Anti-drug antibodies (ADA) against belantamab
Measured: Up to approximately 71 weeks
Titers of ADA against belantamab
Measured: Up to approximately 71 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start16 Oct 2026 (estimated)
- Primary completion5 Aug 2027 (estimated)
- Study completion18 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742527
- Sponsor's protocol ID
- 309296
- Acronym
- DynaMMic-2
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase 1b, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Subcutaneous Belantamab (BCMAb) Formulation With rHuPH20 Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care
- ClinicalTrials.gov ID
- NCT07742527
- Acronym / sponsor ID
- DynaMMic-2 / 309296
- Conditions
- Multiple Myeloma
- Keywords
- Belantamab, Monoclonal antibody, B cell Maturation Antigen (BCMA), Subcutaneous belantamab (BCMAb), Intravenous, Subcutaneous, Multiple myeloma, Standard of care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 18 Mar 2030 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1 | Experimental | Drug: Belantamab SC, Drug: Belantamab IV, Drug: Recombinant Human Hyaluronidase PH20 (rHuPH20), Drug: Standard of careParticipants 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. |
| Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1 | Experimental | Drug: Belantamab SC, Drug: Belantamab IV, Drug: Recombinant Human Hyaluronidase PH20 (rHuPH20), Drug: Standard of careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab SCAlso: GSK2857914Belantamab will be administered via SC route. | Drug | Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1, Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1 |
| Belantamab IVAlso: GSK2857914Belantamab will be administered via IV route. | Drug | 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)rHuPH20 will be administered via SC route. | Drug | Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1, Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1 |
| Standard of careParticipants will receive standard of care: Lenalidomide and/or anti-CD38 mAb as maintenance therapy. | Drug | Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1, Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1 |
Primary outcome
Bioavailability of belantamab
Time frame: Up to approximately 42 weeks
Maximum observed plasma concentration (Cmax) of belantamab
Time frame: Up to approximately 42 weeks
Area under concentration-time curve (AUC) of belantamab
Time frame: Up to approximately 42 weeks
Plasma concentration of belantamab
Time frame: Up to approximately 42 weeks
Number of Participants with Adverse Events (AE)
Time frame: Up to approximately 42 weeks
Number of participants with changes in laboratory parameters
Time frame: Up to approximately 42 weeks
Number of participants with changes in vital signs
Time frame: Up to approximately 42 weeks
2 secondary outcomes
Number of participants with Anti-drug antibodies (ADA) against belantamab
Time frame: Up to approximately 71 weeks
Titers of ADA against belantamab
Time frame: Up to approximately 71 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belantamab SC, Belantamab IV and Recombinant Human Hyaluronidase PH20 (rHuPH20) in people with Multiple Myeloma, run by GlaxoSmithKline.
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 10 inclusion and 26 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of belantamab (time frame: Up to approximately 42 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.