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

Sponsor
GlaxoSmithKline
Study ID
NCT07742527
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab SC — DRUG
    Belantamab will be administered via SC route.
  • Belantamab IV — DRUG
    Belantamab will be administered via IV route.
  • Recombinant Human Hyaluronidase PH20 (rHuPH20) — DRUG
    rHuPH20 will be administered via SC route.
  • Standard of care — DRUG
    Participants will receive standard of care: Lenalidomide and/or anti-CD38 mAb as maintenance therapy.

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Oct 16, 2026
Status verified
Jul 2026
Primary completion
Aug 5, 2027
Completion
Mar 18, 2030

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1
    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.
  • Experimental: Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1
    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.

Primary Outcome Measure

Bioavailability of belantamab [ Time Frame: Up to approximately 42 weeks ]

Central Contacts

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