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| ID | Type | Description | Link |
|---|---|---|---|
| 68284528MMY2003 | Other Identifier | Janssen Research & Development, LLC | |
| 2018-004124-10 | EudraCT Number | ||
| 2023-506587-13-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-68284528 | Experimental | Single group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A (Progressive disease post 1-3 prior lines of therapy), Cohort B (Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma [NDMM], standard risk [International Staging System Stage I/II] and post initial therapy); Cohort E(NDMM,transplant not planned, high risk disease) will first receive quadruplet induction regimen of daratumumab, bortezomib, lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Enrollment is closed for Cohorts A,B,C,D,E and F. For US sites only: Part B:Cohort G (NDMM, transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-68284528 | Drug | Participants in Cohorts A,B,C, D, E, F and Cohort G (for US sites only) will receive JNJ-68284528 intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At least 1 year after JNJ-68284528 infusion on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 8 years and 10 months |
| Cohorts A, B, C, D, E, and F: VGPR or Better Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of California San Diego | San Diego | California | 92037 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36095849 | Derived | Cohen AD, Mateos MV, Cohen YC, Rodriguez-Otero P, Paiva B, van de Donk NWCJ, Martin T, Suvannasankha A, De Braganca KC, Corsale C, Schecter JM, Varsos H, Deraedt W, Wang L, Vogel M, Roccia T, Xu X, Mistry P, Zudaire E, Akram M, Nesheiwat T, Pacaud L, Avivi I, San-Miguel J. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other BCMA-targeting agents. Blood. 2023 Jan 19;141(3):219-230. doi: 10.1182/blood.2022015526. |
| Label | URL |
|---|---|
| Related Info | View source |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Lenalidomide | Drug | Some participants in Cohort D and all participants in Cohorts E and Cohort G (for US sites only) will also receive lenalidomide capsules orally. |
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| Daratumumab | Drug | Participants in Cohorts E and Cohort G (for US sites only) will also receive daratumumab subcutaneous (SC) injection. |
|
| Bortezomib | Drug | Participants in Cohorts E will also receive bortezomib subcutaneously. |
|
| Dexamethasone | Drug | Participants in Cohorts E and Cohort G (for US sites only) will also receive dexamethasone orally or intravenously. |
|
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.
| 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. | Up to 8 years and 10 months |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | Up to 8 years and 10 months |
| Number of Participants with Laboratory Abnormalities | Number of participants with laboratory abnormalities will be reported. | Up to 8 years and 10 months |
| Number of Participants with Vital Signs Abnormalities | Number of participants with vital signs abnormalities will be reported. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 8 years and 10 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63108 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Levine Cancer Institute, Carolinas HealthCare System | Charlotte | North Carolina | 28204 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health And Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | United States |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHRU de Lille Hopital Claude Huriez | Lille | 59037 | France |
| C.H.U. Hotel Dieu - France | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Sheba Medical Center Tel Hashomer | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| King Faisal Specialist Hospital & Research Center | Riyadh | 11211 | Saudi Arabia |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| C556306 | daratumumab |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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