An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments

Sponsor
GlaxoSmithKline
Study ID
NCT03828292
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin will be administered as an intravenous infusion.
  • Bortezomib — DRUG
    Bortezomib solution for injection will be administered subcutaneously.
  • Dexamethasone — DRUG
    Dexamethasone tablets will be administered orally.
  • Pomalidomide — DRUG
    Pomalidomide capsules will be administered orally.

Study Details

Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation antigen (BCMA) expressed on tumor cells of all participants with multiple myeloma. This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 when given as monotherapy (Part 1) or given as combination therapy (Part 2). Dose escalation will follow a 3+3 design.

Key Dates

Start date
Mar 14, 2019
Status verified
Jul 2025
Primary completion
Apr 6, 2023
Completion
Sep 5, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Belantamab mafodotin Monotherapy
  • Experimental: Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone
  • Experimental: Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone

Primary Outcome Measure

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 21 ]

Related Studies