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A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2022-502446-27-00
Other:
#64407564MMY3009
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Trials at a glance
Status
Enrolling
Condition
Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Bortezomib
Dexamethasone
Elotuzumab
Pomalidomide
Talquetamab
Teclistamab
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
January 22, 2024
Trial end date
March 31, 2028
CT.gov ID
#NCT06208150
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
The purpose of this study is to compare the effectiveness of either talquetamab plus
pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab,
pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone
(PVd).
Primary outcome measures
- Progression Free Survival (PFS)
Secondary outcome measures
- Overall Response Rate (ORR)
- Complete Response (CR) or Better Rate
- Very Good Partial Response (VGPR) or Better Rate
- Minimal Residual Disease (MRD)-negative CR Rate
- Overall Survival (OS)
- Progression Free Survival on Next-line Therapy (PFS2)
- Time to Next Treatment (TTNT)
- Serum Concentration of Talquetamab and Teclistamab
- Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
- Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
- Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
- Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
- Number of Participants with Adverse Events (AEs) by Severity
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