Trial · NCT04133636
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD) | At least 1 year after JNJ-68284528 infusion on Day 1 | MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate as defined by the International Myeloma Working Group (IMWG) criteria. |
| Primary | For US sites only: Cohort G: Percentage of Participants with Sustained MRD Negative Complete Response (CR) | At least 1 year after JNJ-68284528 infusion on Day 1 | Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by next-generation sequencing (NGS) or next generation flowcytometry (NGF) with sensitivity of 10\^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between. |
| Secondary | Overall Response Rate (ORR) | Up to 8 years and 10 months | ORR is defined as the percentage of participants who achieve a partial response (PR) or better according to the IMWG criteria. |
| Secondary | Cohorts A, B, C, D, E, and F: VGPR or Better Rate | Up to 8 years and 10 months | The VGPR or better rate (stringent complete responses \[sCR\] + complete response \[CR\] + VGPR), defined as the percentage of participants achieving VGPR or better response according to IMWG criteria during or after the study treatment. |
| Secondary | Cohorts A, B, C, D, E, and F: Clinical Benefit Rate (CBR) | Up to 8 years and 10 months | CBR is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) + minimal response (MR) according to the IMWG criteria. |
| Secondary | Duration of Response (DOR) | Up to 8 years and 10 months | DOR will be calculated among responders from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. |
| Secondary | Time to Response (TTR) | Up to 8 years and 10 months | TTR is defined as the time from the date of the initial infusion of JNJ-68284528 and the first efficacy evaluation that the participant has met all criteria for PR or better. |
| Secondary | Cohorts A, B, C, D, E, and F: MRD Negative Rate at 12 Months for Participants who Achieve a Complete Response (CR) | 12 months | MRD negative rate at 12 months for participants who achieved a complete response (CR) is defined as the percentage of participants who are MRD negative by bone marrow aspirate and meet the IMWG criteria for CR at 12 months after initial dose of JNJ-68284528 and before disease progression or starting subsequent therapy including retreatment of JNJ-68284528. |
| Secondary | Time to MRD Negativity | Up to 8 years and 10 months | Time to MRD negativity will be calculated in participants who are MRD negative by bone marrow aspirate from the date of the initial infusion of JNJ-68284528 to the initial date of reaching the MRD negative status. |
| Secondary | Duration of MRD Negativity | Up to 8 years and 10 months | Duration of MRD negativity will be calculated among participants who are MRD negative by bone marrow aspirate from the date of initial MRD negativity to the date when MRD is detected at the same threshold (10\^-5). |
| Secondary | Cohorts A, B, C, D, E, and F: MRD Negative Rate Across Clinical Response | Up to 8 years and 10 months | MRD negative rate across clinical response groups will be assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR) or very good partial response (VGPR) according to the IMWG criteria during or after the study treatment. MRD negative rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any timepoint. |
| Secondary | Number of Participants with Adverse Events by Severity | Up to 8 years and 10 months | An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). CRS and ICANS will be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading. |
| Secondary | Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability | Up to 8 years and 10 months | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Number of Participants with Laboratory Abnormalities | Up to 8 years and 10 months | Number of participants with laboratory abnormalities will be reported. |
| Secondary | Number of Participants with Vital Signs Abnormalities | Up to 8 years and 10 months | Number of participants with vital signs abnormalities will be reported. |
| Secondary | Cohorts A, B, C, D, E, and F: Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA | Up to 1 year | Levels of expression of BCMA-expressing plasma cells in the bone marrow as well as the level of soluble BCMA in blood will be reported. |
| Secondary | Cohorts A, B, C, D, E, and F: Systemic Inflammatory Cytokine Concentrations | Up to 1 year | Blood cytokine concentrations (Interleukin \[IL\]-6, IL-15, IL-10, and Interferon \[IFN-gamma\]) will be measured for biomarker assessment. |
| Secondary | Cohorts A, B, C, D, E, and F: Levels of JNJ-68284528 T Cell Expansion (proliferation), and Persistence | Up to 1 year | Levels of JNJ-68284528 T cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported. |
| Secondary | Cohorts A, B, C, D, E, and F: Number of Participants with Anti-JNJ-68284528 Antibodies | Up to 1 year | Number of participants exhibiting anti-drug antibodies for JNJ-68284528 will be reported. |
| Secondary | For US sites only: Cohort G: Percentage of Participants with Complete Response (CR) or Better | Up to 8 years and 10 months | CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
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.
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