Talquetamab for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
New Jersey Hematology Oncology Ass., Brick, NJ
Multiple Myeloma+2 More
Talquetamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Multiple Myeloma
  • Relapsed Or Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: Up to 4 years

Year 4
Change from Baseline in EuroQol 5-Dimension Questionnaire 5-Level (EQ-5D-5L)
Change from Baseline in EuroQol 5-Dimension Questionnaire 5-Level (FACT-G)
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
Year 3
Overall Response Rate (ORR)
Progression-free Survival (PFS)
Up to 4 years
Complete Response (CR) or Better Response Rate
Number of Participants with AEs by Severity
Number of Participants with Abnormalities in Clinical Laboratory Assessments
Number of Participants with Adverse Events (AEs)
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab
Overall Survival (OS)
Serum Concentration of Talquetamab
Time to Progression on the First Subsequent Line of Therapy or Death, Whichever Comes First (PFS2)
Time to Sustained Worsening in EORTC-QLQ-C30
Time to Sustained Worsening in EQ-5D-5L
Time to Sustained Worsening in FACT-G
Titers of ADAs to Talquetamab
Very Good Partial Response (VGPR) or Better Response Rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm B: Belantamab Mafodotin
1 of 2
Arm A: Talquetamab
1 of 2
Active Control
Experimental Treatment

216 Total Participants · 2 Treatment Groups

Primary Treatment: Talquetamab · No Placebo Group · Phase 3

Arm A: Talquetamab
Drug
Experimental Group · 1 Intervention: Talquetamab · Intervention Types: Drug
Arm B: Belantamab Mafodotin
Drug
ActiveComparator Group · 1 Intervention: Belantamab Mafodotin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
Closest Location: New Jersey Hematology Oncology Ass. · Brick, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Multiple Myeloma
0 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
916 Previous Clinical Trials
6,326,652 Total Patients Enrolled
62 Trials studying Multiple Myeloma
16,987 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
705 Previous Clinical Trials
3,899,947 Total Patients Enrolled
45 Trials studying Multiple Myeloma
12,125 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have progressive disease based on the investigator's determination of response by IMWG criteria on or after their last regimen.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening.
You are a female participant of childbearing potential who has a negative serum pregnancy test at screening, and who agrees to further serum or urine pregnancy tests during the study and within 6 months after receiving the last dose of study treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.