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A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2023-506588-32-00
EudraCT:
J&J ID:
#CR108695
Other:
#68284528MMY3002
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Trials at a glance
Status
Enrollment complete
Condition
Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Bortezomib
Cilta-cel
Daratumumab
Dexamethasone
Pomalidomide
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
June 12, 2020
Trial end date
April 9, 2029
CT.gov ID
#NCT04181827
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
Primary outcome measures
- Progression Free Survival (PFS)
Secondary outcome measures
- Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR)
- Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5)
- Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months
- Percentage of Participants Who Achieved Sustained MRD-negative Status
- Overall Survival (OS)
- Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score
- Overall Response Rate (ORR)
- Progression Free Survival on Next-line Therapy (PFS2)
- Number of Participants With Treatment-emergent Adverse Events (AEs)
- Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity
- Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B)
- Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B)
- Change From Baseline in Levels of JNJ-68284528 T Cell Expansion (Proliferation), and Persistence on Participants Who Received Cilta-cel as Study Treatment (Arm B)
- Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B)
- Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 Item (EORTC-QLQ-C30) Scale Score
- Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore
- Change From Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Scale Score
- Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
- Number of Participants in Health-Related Quality of Life as Assessed by The Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item
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