Trial · 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
NCT04181827, Phase 3, Active not recruiting, Janssen Research & Development, LLC; results first posted 2025-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04181827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04181827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04181827
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 419 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma
- Interventions
- Cilta-cel, Pomalidomide, Bortezomib, Dexamethasone, Daratumumab
- First posted
- 2019-12-02
- Last updated
- 2026-11-03
- Other registries' IDs
- eudract:2019-001413-16
- Results first posted
- 2025-05-20
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm A: Standard Therapy: PVd or DPd | 11.79 | 95% Confidence Interval 9.66 to 14.00 | months | |
| Progression Free Survival (PFS) | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | NA | 95% Confidence Interval 34.50 to NA | months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Standard Therapy: PVd or DPd | 211 | |
| Overall Study | STARTED | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 208 | |
| Overall Study | Treated (Safety Analysis Set) | Arm A: Standard Therapy: PVd or DPd | 208 | |
| Overall Study | Treated (Safety Analysis Set) | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 208 | |
| Overall Study | COMPLETED | Arm A: Standard Therapy: PVd or DPd | 0 | |
| Overall Study | COMPLETED | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Standard Therapy: PVd or DPd | 211 | |
| Overall Study | NOT COMPLETED | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 208 |
Source ClinicalTrials.gov
Adverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Standard Therapy: PVd or DPd | 57 | 208 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 110 | 208 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Standard Therapy: PVd or DPd | 16 | 208 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 27 | 208 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm A: Standard Therapy: PVd or DPd | 29 | 208 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 47 | 208 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Standard Therapy: PVd or DPd | 178 | 208 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 187 | 208 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Standard Therapy: PVd or DPd | 67 | 208 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 113 | 208 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Standard Therapy: PVd or DPd | 83 | 211 |
| Total, all-cause mortality | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 50 | 208 |
| Total, other adverse events | Arm A: Standard Therapy: PVd or DPd | 207 | 208 |
| Total, other adverse events | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 208 | 208 |
| Total, serious adverse events | Arm A: Standard Therapy: PVd or DPd | 98 | 208 |
| Total, serious adverse events | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 98 | 208 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Standard Therapy: PVd or DPd vs Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]): deaths from any cause | Trial comparisons |
| Arm A: Standard Therapy: PVd or DPd vs Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04181827
GET https://conductscience.org/api/trials/v1/NCT04181827/events?page=2