Trial · NCT04181827
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years) | PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease. |
| 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04181827/registered