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A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (CARTITUDE-5)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bortezomib
Dexamethasone
Lenalidomide
Cilta-cel
Cyclophosphamide
Fludarabine
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Newly Diagnosed Multiple Myeloma, Cellular Therapy, CAR-T Therapy, BCMA CAR-T

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
  • Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
  • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
  • A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
  • Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)

Exclusion Criteria:

  • Frailty index of >=2 according to Myeloma Geriatric Assessment score
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
  • Seropositive for human immunodeficiency virus (HIV)
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
  • Participant must not require continuous supplemental oxygen
  • Hepatitis B infection
  • Hepatitis C infection
  • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • Any therapy that is targeted to B-cell maturation antigen (BCMA)

Sites / Locations

  • UCSFRecruiting
  • Yale Cancer CenterRecruiting
  • University of Miami Health SystemRecruiting
  • AdventHealth Cancer InstituteRecruiting
  • University of Iowa Hospitals & ClinicsRecruiting
  • University of KentuckyRecruiting
  • Norton Cancer InstituteRecruiting
  • University Of Maryland Medical CenterRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • Henry Ford Cancer InstituteRecruiting
  • Columbia University Medical CenterRecruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • New York Presbyterian-Weill Cornell Medical CollegeRecruiting
  • Levine Cancer InstituteRecruiting
  • Thomas Jefferson UniversityRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • University of VirginiaRecruiting
  • Medical College Of WisconsinRecruiting
  • Hospital AlemanRecruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Hospital Privado Centro Medico de CordobaRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • St. Vincent's Hospital MelbourneRecruiting
  • Austin HealthRecruiting
  • Royal Brisbane and Womens HospitalRecruiting
  • Alfred HealthRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Fiona Stanley HospitalRecruiting
  • Calvary Mater Newcastle HospitalRecruiting
  • Western Sydney Local Health DistrictRecruiting
  • Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für HämatologieRecruiting
  • Krankenhaus der Elisabethinen LinzRecruiting
  • LKH - Universitätsklinikum der PMU SalzburgRecruiting
  • Medical University of Vienna,Universitätsklinik für Innere Medizin IRecruiting
  • Universitair Ziekenhuis - AntwerpenRecruiting
  • AZ St.-Jan Brugge-Oostende AVRecruiting
  • UZ GentRecruiting
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Hospital Sao RafaelRecruiting
  • Fundacao Antonio Prudente - A.C. Camargo Cancer CenterRecruiting
  • Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
  • Tom Baker Cancer CentreRecruiting
  • Vancouver General HospitalRecruiting
  • Juravinski Cancer CentreRecruiting
  • Princess Margaret Cancer Centre University Health NetworkRecruiting
  • Hopital Maisonneuve-RosemontRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • Odense UniversitetshospitalRecruiting
  • Helsinki University HospitalRecruiting
  • Oulu University HospitalRecruiting
  • Turku University HospitalRecruiting
  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude HuriezRecruiting
  • C.H.U. Hotel Dieu - FranceRecruiting
  • Hopital Saint-LouisRecruiting
  • CHU Poitiers - Hôpital la MilétrieRecruiting
  • Institut Universitaire du cancer de Toulouse-OncopoleRecruiting
  • Charité - Universitätsmedizin Berlin, Campus Benjamin FranklinRecruiting
  • Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
  • Universitatsklinikum FreiburgRecruiting
  • Universitaetsklinikum Hamburg EppendorfRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • Universitaetsklinikum LeipzigRecruiting
  • Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting
  • Klinikum Großhadern der Ludwig-Maximilians-UniversitätRecruiting
  • Universitaetsklinikum RegensburgRecruiting
  • Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-GermanyRecruiting
  • Universitätsklinikum WürzburgRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • Attikon University General Hospital of AtticaRecruiting
  • G.PapanikolaouRecruiting
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László TelephelyRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • St James HospitalRecruiting
  • Hadassah University Hospita - Ein KeremRecruiting
  • Sheba Medical Center Tel HashomerRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Juntendo University HospitalRecruiting
  • Kyushu University HospitalRecruiting
  • Hyogo Medical University HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • University Hospital Kyoto Perfectural University of MedicineRecruiting
  • Nagoya City University HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Japanese Red Cross Medical CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • University Medical Center GroningenRecruiting
  • UMC RadboudRecruiting
  • Erasmus MCRecruiting
  • Oslo universitetssykehus HF, RikshospitaletRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w GliwicachRecruiting
  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z DukliRecruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Instytut Hematologii i TransfuzjologiiRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
  • Instituto Portugues de OncologiaRecruiting
  • Instituto Portugues de OncologiaRecruiting
  • Hosp. de La Santa Creu I Sant PauRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Instituto Catalan Deoncologia Hospital Duran I ReynalsRecruiting
  • Hosp. Gral. Univ. Gregorio MaranonRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. Virgen de La ArrixacaRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • Hosp. Univ. Marques de ValdecillaRecruiting
  • Hosp. Virgen Del RocioRecruiting
  • Hosp. Univ. I Politecni La FeRecruiting
  • Sahlgrenska University Hospital
  • UniversitetssjukhusetRecruiting
  • Skane University HospitalRecruiting
  • Universitatsspital BaselRecruiting
  • INSELSPITAL, Universitätsspital BernRecruiting
  • Kantonsspital St.GallenRecruiting
  • University Hospitals Birmingham NHS Trust,Recruiting
  • Bristol Royal InfirmaryRecruiting
  • Leeds Teaching Hospitals NHS TrustRecruiting
  • University College HospitalRecruiting
  • King's College HospitalRecruiting
  • Manchester Royal InfirmaryRecruiting
  • The Royal Marsden NHS Trust SuttonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: VRd+Rd (Standard Therapy)

Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)

Arm Description

Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.

Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Sustained Minimal Residual Disease (MRD) Negative CR
Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status.
MRD Negative CR at 9 Months
MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date.
Overall MRD Negative CR
Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy.
Overall Survival (OS)
Overall survival is measured from the date of randomization to the date of the participant's death.
Complete Response or Better
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.
Time to Subsequent Anti-myeloma Therapy
Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.
Progression Free Survival on Next-line Therapy (PFS2)
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.
Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs
Number of participants with AEs, abnormalities in laboratory parameters (complete blood count [CBC] with differential, coagulation, chimeric antigen receptor T cell [CAR-T] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported.
Arm B: Systemic Cytokine Concentrations
Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.
Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers
CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response.
Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)
Levels of soluble BCMA will be reported.
Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence
Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Arm B: Number of Participants with Anti-cilta-cel Antibodies
Number of participants with anti-cilta-cel antibodies will be reported.
Arm B: Number of Participants with Presence of Replication Competent Lentivirus
Number of participants with presence of replication competent lentivirus will be reported.
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items
The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Time to Worsening of Symptoms, Functioning and Overall Well-being
Time to worsening is measured as the interval from the date of randomization to the start date of worsening in MySIm-Q symptom, impact, or total scores.

Full Information

First Posted
June 10, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04923893
Brief Title
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
Acronym
CARTITUDE-5
Official Title
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
June 11, 2026 (Anticipated)
Study Completion Date
January 16, 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
Detailed Description
Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis of this study is that in participants with newly diagnosed MM, treatment with VRd induction followed by a single administration of cilta-cel will significantly improve progression free survival compared to Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Rd maintenance. The study will screen participants with newly diagnosed MM who are not planned to receive autologous stem cell transplant (ASCT) as initial therapy. This study will be conducted in 4 phases: Screening (up to 28 days), Pre-randomization Treatment, Treatment, and Follow-up. Assessments like patient-reported outcome(s) (PROs), electrocardiogram (ECG), vital signs and pharmacokinetics will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, assessment of cardiac function, Immune-Effector Cell-Associated Encephalopathy (ICE) and handwriting assessments (only for Arm B) and Eastern Cooperative Oncology Group (ECOG) performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 12 years 5 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Newly Diagnosed Multiple Myeloma, Cellular Therapy, CAR-T Therapy, BCMA CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: VRd+Rd (Standard Therapy)
Arm Type
Experimental
Arm Description
Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.
Arm Title
Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)
Arm Type
Experimental
Arm Description
Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered SC.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Cilta-cel
Other Intervention Name(s)
JNJ-68284528
Intervention Description
Cilta-cel infusion will be administered.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine will be administered intravenously.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 4 years and 5 months
Secondary Outcome Measure Information:
Title
Sustained Minimal Residual Disease (MRD) Negative CR
Description
Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status.
Time Frame
Up to 12 years and 5 months
Title
MRD Negative CR at 9 Months
Description
MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date.
Time Frame
9 months
Title
Overall MRD Negative CR
Description
Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy.
Time Frame
Up to 12 years and 5 months
Title
Overall Survival (OS)
Description
Overall survival is measured from the date of randomization to the date of the participant's death.
Time Frame
Up to 12 years and 5 months
Title
Complete Response or Better
Description
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.
Time Frame
Up to 12 years and 5 months
Title
Time to Subsequent Anti-myeloma Therapy
Description
Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.
Time Frame
Up to 12 years and 5 months
Title
Progression Free Survival on Next-line Therapy (PFS2)
Description
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.
Time Frame
Up to 12 years and 5 months
Title
Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs
Description
Number of participants with AEs, abnormalities in laboratory parameters (complete blood count [CBC] with differential, coagulation, chimeric antigen receptor T cell [CAR-T] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported.
Time Frame
Up to 12 years and 5 months
Title
Arm B: Systemic Cytokine Concentrations
Description
Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.
Time Frame
Up to Day 112
Title
Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers
Description
CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response.
Time Frame
Up to 12 years and 5 months
Title
Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)
Description
Levels of soluble BCMA will be reported.
Time Frame
Up to 1 year
Title
Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence
Description
Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Time Frame
Up to 12 years and 5 months
Title
Arm B: Number of Participants with Anti-cilta-cel Antibodies
Description
Number of participants with anti-cilta-cel antibodies will be reported.
Time Frame
Up to 12 years and 5 months
Title
Arm B: Number of Participants with Presence of Replication Competent Lentivirus
Description
Number of participants with presence of replication competent lentivirus will be reported.
Time Frame
Up to 12 years and 5 months
Title
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Description
The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Time Frame
Baseline up to 12 years and 5 months
Title
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
Description
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
Time Frame
Baseline up to 12 years and 5 months
Title
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Description
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline up to 12 years and 5 months
Title
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Description
The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Time Frame
Baseline up to 12 years and 5 months
Title
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items
Description
The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Time Frame
Up to 161 days
Title
Time to Worsening of Symptoms, Functioning and Overall Well-being
Description
Time to worsening is measured as the interval from the date of randomization to the start date of worsening in MySIm-Q symptom, impact, or total scores.
Time Frame
Up to 12 year and 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio Eastern Cooperative Oncology Group Performance Status grade of 0 or 1 Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study. Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required) Exclusion Criteria: Frailty index of >=2 according to Myeloma Geriatric Assessment score Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5 Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM Stroke or seizure within 6 months of signing Informed Consent Form (ICF) Seropositive for human immunodeficiency virus (HIV) Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd Participant must not require continuous supplemental oxygen Hepatitis B infection Hepatitis C infection Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target Any therapy that is targeted to B-cell maturation antigen (BCMA)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
First Name & Middle Initial & Last Name or Official Title & Degree
SparkCures Patient Support (US only)
Phone
(888) 676-2873
Email
support+nct@sparkcures.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
AdventHealth Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32832
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Presbyterian-Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Aleman
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Brisbane and Womens Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
8006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Western Sydney Local Health District
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Krankenhaus der Elisabethinen Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medical University of Vienna,Universitätsklinik für Innere Medizin I
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis - Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ St.-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Completed
Facility Name
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Individual Site Status
Completed
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
City
Sao Paulo
ZIP/Postal Code
01509900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Individual Site Status
Recruiting
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
C.H.U. Hotel Dieu - France
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint-Louis
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Poitiers - Hôpital la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du cancer de Toulouse-Oncopole
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Großhadern der Ludwig-Maximilians-Universität
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University General Hospital of Attica
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
G.Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
St James Hospital
City
Dublin
ZIP/Postal Code
D08 NHY1
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Hadassah University Hospita - Ein Kerem
City
Jerusalem
ZIP/Postal Code
P.O.B. 12000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Medical University Hospital
City
Hyôgo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Oslo universitetssykehus HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
City
Gliwice
ZIP/Postal Code
44102
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
52-007
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instituto Portugues de Oncologia
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Portugues de Oncologia
City
Porto
ZIP/Postal Code
4200072
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Catalan Deoncologia Hospital Duran I Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Completed
Facility Name
Universitetssjukhuset
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Universitatsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
INSELSPITAL, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital St.Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
University Hospitals Birmingham NHS Trust,
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds,
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Trust Sutton
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Links:
URL
https://sparkcures.com/trial/1182/nct04923893?utm_source=ctgov&utm_medium=organic&utm_campaign=cartitude5
Description
Click here to learn more about the 68284528MMY3004 (CARTITUDE-5) trial (US only)

Learn more about this trial

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

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