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A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
Relapsed or Refractory Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2021-000202-22-00
EudraCT:
J&J ID:
#CR109082
Other:
#64407564MMY3002
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Trials at a glance
Status
Enrollment complete
Condition
Relapsed or Refractory Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Daratumumab
Dexamethasone
Pomalidomide
Talquetamab
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
October 13, 2022
Trial end date
May 25, 2028
CT.gov ID
#NCT05455320
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).
Primary outcome measures
- Progression-Free Survival (PFS)
Secondary outcome measures
- Overall Response (Partial Response [PR] or Better)
- Very Good Partial Response (VGPR) or Better Rate
- Complete Response (CR) or Better Rate
- Overall Minimal Residual Disease (MRD) Negative CR
- Overall Survival (OS)
- Progression-free Survival on Next-line Therapy (PFS2)
- Time to Next Therapy (TTNT)
- Number of Participants with Adverse Events (AEs)
- Number of Participants with AEs by Severity
- Serum Concentrations of Talquetamab
- Serum Concentrations of Daratumumab
- Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab
- Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab
- Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
- Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
- Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
- Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
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