The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
208
Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously.
Some participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally.
Participants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection.
Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD)
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.
Time frame: At least 1 year after JNJ-68284528 infusion on Day 1
For US sites only: Cohort G: Percentage of Participants with Sustained MRD Negative Complete Response (CR)
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.
Time frame: At least 1 year after JNJ-68284528 infusion on Day 1
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve a partial response (PR) or better according to the IMWG criteria.
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: VGPR or Better Rate
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.
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) + minimal response (MR) according to the IMWG criteria.
Time frame: Up to 8 years and 10 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants in Cohorts E will also receive bortezomib subcutaneously.
Participants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously.
University Of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
...and 37 more locations
Duration of Response (DOR)
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.
Time frame: Up to 8 years and 10 months
Time to Response (TTR)
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.
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: MRD Negative Rate at 12 Months for Participants who Achieve a Complete Response (CR)
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.
Time frame: 12 months
Time to MRD Negativity
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.
Time frame: Up to 8 years and 10 months
Duration of MRD Negativity
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).
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: MRD Negative Rate Across Clinical Response
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.
Time frame: Up to 8 years and 10 months
Number of Participants with Adverse Events by Severity
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.
Time frame: Up to 8 years and 10 months
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
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.
Time frame: Up to 8 years and 10 months
Number of Participants with Laboratory Abnormalities
Number of participants with laboratory abnormalities will be reported.
Time frame: Up to 8 years and 10 months
Number of Participants with Vital Signs Abnormalities
Number of participants with vital signs abnormalities will be reported.
Time frame: Up to 8 years and 10 months
Cohorts A, B, C, D, E, and F: Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA
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.
Time frame: Up to 1 year
Cohorts A, B, C, D, E, and F: Systemic Inflammatory Cytokine Concentrations
Blood cytokine concentrations (Interleukin \[IL\]-6, IL-15, IL-10, and Interferon \[IFN-gamma\]) will be measured for biomarker assessment.
Time frame: Up to 1 year
Cohorts A, B, C, D, E, and F: Levels of JNJ-68284528 T Cell Expansion (proliferation), and Persistence
Levels of JNJ-68284528 T cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Time frame: Up to 1 year
Cohorts A, B, C, D, E, and F: Number of Participants with Anti-JNJ-68284528 Antibodies
Number of participants exhibiting anti-drug antibodies for JNJ-68284528 will be reported.
Time frame: Up to 1 year
For US sites only: Cohort G: Percentage of Participants with Complete Response (CR) or Better
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.
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Percentage of Participants with MRD-negative CR or sCR
MRD-negative CR/sCR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS/NGF with sensitivity of 10\^-5, at any time after enrollment and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR/sCR or better.
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Progression-free Survival on Next-line Therapy (PFS2)
PFS2 is defined as the time interval between the start of study treatment and date of event, which is defined as death from any cause or PD as assessed by investigator that starts after the next line of therapy, whichever occurs first.
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Overall Survival (OS)
OS is defined as the time from the start of study treatment to the date of the participant's death.
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Progression-free Survival (PFS)
PFS is defined as the time from the start of study treatment to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Whole Blood
Number of participants with measurable RCL in whole blood will be reported.
Time frame: Up to 8 years and 10 months
For US sites only: Cohort G: Time to Subsequent Anti-Myeloma Therapy
Time to subsequent anti-myeloma treatment is defined as the time from start of study treatment to the start of subsequent anti-myeloma treatment.
Time frame: Up to 8 years and 10 months