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| ID | Type | Description | Link |
|---|---|---|---|
| 68284528MMY2012 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-521975-30-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion. |
|
| Cohort B | Experimental | Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilta-cel | Drug | Cilta-cel will be administered as intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion | Participants in CR or better who achieve MRD-negative status at 12 months after cilta-cel infusion with a sensitivity of 10^-5, prior to progressive disease (PD) or subsequent anti-myeloma therapy will be reported. | At least 12 months after Cilta-cel infusion on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall MRD-negative CR Rate | Overall MRD-negative CR is defined as the percentage of participants who achieve MRD-negative CR with a sensitivity of 10^-5 at any time after enrollment but prior to PD or subsequent anti-myeloma therapy. | From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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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| Cyclophosphamide | Drug | Cyclophosphamide will be administered as intravenous infusion. |
|
| Induction therapy | Drug | Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered. |
|
| Fludarabine | Drug | Fludarabine will be administered as intravenous infusion. |
|
| CR or better status | CR or better is defined as the percentage of participants who achieve a CR or stringent complete response (sCR) according to the most recent international myeloma working group (IMWG) criteria. | From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months) |
| Progression Free Survival (PFS) | PFS is defined as the time from the date of enrollment to the date of first documented PD, as defined in the most recent IMWG criteria, or death due to any cause, whichever occurs first. | From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months) |
| Overall Survival (OS) | OS is measured from the date of enrollment to the date of the participant's death. | Up to 3 years and 4 months |
| Number of Participants with Adverse Event (AE) by Severity | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. | Up to 3 years and 4 months |
| Number of Participants with Abnormalities in Laboratory Parameters | Participants with abnormalities in laboratory parameters (hematology, chemistry) will be reported. | Up to 3 years and 4 months |
| Levels of Cilta-cel T-Cell Expansion, and Persistence | Levels of Cilta-cel T cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported. | Up to 3 years and 4 months |
| Number of Participants with Anti-Cilta-Cel Antibodies | The presence of anti-cilta-cel antibodies will be determined from anti-drug antibody samples collected from each participant. | Up to 3 years and 4 months |
| Percentage of Participants with Presence of Replication-competent Lentivirus (RCL) | Percentage of participants with presence of RCL will be reported. | Up to 3 years and 4 months |
| Moffitt Cancer Center |
| Active, not recruiting |
| Tampa |
| Florida |
| 33612 |
| United States |
| University of Iowa Hospital and Clinics | Active, not recruiting | Iowa City | Iowa | 52242 | United States |
| Memorial Sloan Kettering Cancer Center | Active, not recruiting | New York | New York | 10065 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| Royal Prince Alfred Hospital | Recruiting | Camperdown | 2050 | Australia |
| Austin Hospital | Recruiting | Heidelberg | 3084 | Australia |
| Fiona Stanley Hospital | Recruiting | Murdoch | 6150 | Australia |
| Princess Alexandra Hospital | Recruiting | Woolloongabba | 4102 | Australia |
| Hosp. Univ. Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp. Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Clinica Univ. de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hosp. Virgen Del Rocio | Recruiting | Seville | 41013 | 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D020360 | Neoadjuvant Therapy |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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