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

NCT05461209 | Withdrawn Phase 3 DMC FDA Drug

• 3 other identifiers: CR10923564407564MMY30082022-001442-38
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Relapsed/ Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  ORR is defined as percentage of participants with confirmed best overall response of partial response (PR) or better according to international myeloma working group (IMWG) criteria.

  Up to 1 year 3 months

• Progression-free Survival (PFS)

  PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.

  Up to 1 year 3 months

Secondary Outcomes (16)

• Very Good Partial Response (VGPR) or Better Response Rate

  Up to 4 years

• Complete Response (CR) or Better Response Rate

  Up to 4 years

• Overall Survival (OS)

  Up to 4 years

• Time to Progression on the First Subsequent Line of Therapy or Death, Whichever Comes First (PFS2)

  Up to 4 years

• Number of Participants with Adverse Events (AEs)

  Up to 4 years

Study Arms (2)

Arm A: Talquetamab

EXPERIMENTAL

Participants will receive talquetamab subcutaneously (SC).

Drug: Talquetamab

Arm B: Belantamab Mafodotin

ACTIVE COMPARATOR

Participants will receive belantamab intravenously (IV).

Drug: Belantamab Mafodotin

Interventions

Talquetamab DRUG

Talquetamab will be administered as subcutaneous injection.

Also known as: JNJ-64407564

Arm A: Talquetamab

Belantamab Mafodotin DRUG

Belantamab Mafodotin will be administered as intravenous infusion.

Arm B: Belantamab Mafodotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734, Poland

Location

MeSH Terms

Interventions

talquetamab; belantamab mafodotin

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: October 20, 2022
• Primary Completion: November 15, 2022
• Study Completion: October 31, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

PL (1); US (1)