Last updated: 07/29/2026 18:00:23

A study to evaluate the subcutaneous belantamab (BCMAb) formulation versus intravenous belantamab in participants with multiple myeloma while treated with standard of careDynaMMic-2

GSK study ID
309296
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Cross-over
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Bioavailability of belantamab

Timeframe: Up to approximately 42 weeks

Maximum observed plasma concentration (Cmax) of belantamab

Timeframe: Up to approximately 42 weeks

Area under concentration-time curve (AUC) of belantamab

Timeframe: Up to approximately 42 weeks

Plasma concentration of belantamab

Timeframe: Up to approximately 42 weeks

Number of Participants with Adverse Events (AE)

Timeframe: Up to approximately 42 weeks

Number of participants with changes in laboratory parameters

Timeframe: Up to approximately 42 weeks

Number of participants with changes in vital signs

Timeframe: Up to approximately 42 weeks

Secondary outcomes:

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

Timeframe: Up to approximately 71 weeks

Titers of ADA against belantamab

Timeframe: Up to approximately 71 weeks

Interventions:
Drug: Belantamab SC
Drug: Belantamab IV
Drug: Recombinant Human Hyaluronidase PH20 (rHuPH20)
Drug: Standard of care
Enrollment:
22
Observational study model:
Not applicable
Primary completion date:
2027-05-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Belantamab
Collaborators
Not applicable
Study date(s)
October 2026 to March 2030
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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.
  • 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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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