Overview

A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma

Status:
Not yet recruiting
Trial end date:
2026-10-09
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the efficacy of talquetamab versus belantamab mafodotin in terms of overall response rate (ORR) or progression-free survival (PFS).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
Inclusion Criteria:

- Documented multiple myeloma as defined by the criteria: a) multiple myeloma according
to international myeloma working group (IMWG) diagnostic criteria b) measurable
disease at screening, as assessed by central laboratory, defined by any of the
following i) serum M-protein level greater than or equal to (>=) 1.0 gram per
deciliter (g/dL) ii) urine M-protein level >=200 milligram (mg)/24 hours iii) Light
chain multiple myeloma without measurable M-protein in the serum or the urine: serum
free light chain (sFLC) >=10 milligram per deciliter (mg/dL) (central laboratory) and
abnormal serum immunoglobulin kappa lambda free light chain (FLC) ratio

- Received at least 4 prior antimyeloma therapies including an anti-cluster of
differentiation 38 (CD38) monoclonal antibody (mAb) (alone or in combination) and is
refractory per IMWG criteria to at least one proteasome inhibitor (PI), and one
immunomodulatory drug (IMiD)

- Documented evidence of progressive disease based on investigator's determination of
response by IMWG criteria on or after their last regimen

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at
screening

- A female participant of childbearing potential must have a negative serum pregnancy
test at screening, and must agree to further serum or urine pregnancy tests during the
study and within 6 months after receiving the last dose of study treatment

Exclusion Criteria:

- Contraindications or life-threatening known allergies, hypersensitivity, or
intolerance to any study drug or its excipients

- Stroke or seizure within 6 months prior to signing informed consent form (ICF)

- Prior or concurrent exposure to belantamab mafodotin

- Current corneal epithelial disease except mild punctate keratopathy

- Known active central nervous system (CNS) involvement or exhibits clinical signs of
meningeal involvement of multiple myeloma. If either is suspected, negative whole
brain magnetic resonance imaging (MRI) and lumbar cytology are required