Trial · NCT04181827
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years) | The intent-to-treat (ITT) analysis set included all participants who were randomized in the study. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR) | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5) | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months | From randomization (Day 1) up to 12 months +/- 3 months | |||
| SECONDARY | Percentage of Participants Who Achieved Sustained MRD-negative Status | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Overall Survival (OS) | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Overall Response Rate (ORR) | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Progression Free Survival on Next-line Therapy (PFS2) | From randomization (Day 1) up to 7 years | |||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (AEs) | From Cycle 1 Day 1 up to 7 years | |||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity | From Cycle 1 Day 1 up to 7 years | |||
| SECONDARY | Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B) | From baseline (Cycle 1 Day 1) up to 7 years | |||
| SECONDARY | Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B) | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | |||
| SECONDARY | 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) | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | |||
| SECONDARY | Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B) | From Cycle 1 Day 1 up to 7 years | |||
| SECONDARY | 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 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | |||
| SECONDARY | Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | |||
| SECONDARY | 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 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | |||
| SECONDARY | Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | |||
| SECONDARY | 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 | From randomization (Day 1) up to 7 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04181827/outcomes