A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
GlaxoSmithKline
Study ID
NCT07224672
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amyloidosis

Eligibility Criteria

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

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin will be administered
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered
  • Bortezomib — DRUG
    Bortezomib will be administered
  • Dexamethasone — DRUG
    Dexamethasone will be administered

Study Details

The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .

Key Dates

First listed
Nov 5, 2025
Start date
Jun 24, 2026
Status verified
Jul 2026
Primary completion
Jan 12, 2033
Completion
Jan 12, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose optimization phase: Belantamab mafodotin dose level 1 + CyBorD
    Adult participants with newly diagnosed amyloid light chain (AL) amyloidosis will receive Belantamab mafodotin dose level 1 in combination with CyBorD in dose optimization phase.
  • Experimental: Dose optimization phase: Belantamab mafodotin dose level 2+ CyBorD
    Adult participants with newly diagnosed AL amyloidosis will receive Belantamab mafodotin dose level 2 in combination with CyBorD in dose optimization phase.
  • Experimental: Dose expansion phase: Belantamab mafodotin + CyBorD
    Adult participants with newly diagnosed AL amyloidosis will receive belantamab mafodotin at selected dose level from dose optimization phase in combination with CyBorD in dose expansion phase.

Primary Outcome Measure

Overall complete hematologic response (CHR) rate [ Time Frame: Up to approximately 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteRochesterMinnesota55905
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Shaji Kumar (PRINCIPAL_INVESTIGATOR)

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GSK Investigational Site· Rochester, MN

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