A Study to Evaluate the Subcutaneous Belantamab (BCMAb) Formulation Versus Intravenous Belantamab in Participants With Multiple Myeloma While Treated With Standard of Care
NCT07742527 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-08-03
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.
Conditions
Interventions
- DRUG
-
Recombinant Human Hyaluronidase PH20 (rHuPH20)
rHuPH20 will be administered via SC route.
- DRUG
-
Standard of care
Participants will receive standard of care: Lenalidomide and/or anti-CD38 mAb as maintenance therapy.
- DRUG
-
Belantamab SC
Belantamab will be administered via SC route.
- DRUG
-
Belantamab IV
Belantamab will be administered via IV route.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-16
- Primary Completion
- 2027-08-05
- Completion
- 2030-03-18
- FDA Drug
- Yes
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