CARTITUDE-5: 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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04923893
Collaborator
(none)
650
Enrollment
153
Locations
2
Arms
148.9
Anticipated Duration (Months)
4.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
650 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 19, 2021
Anticipated Primary Completion Date :
Jun 11, 2026
Anticipated Study Completion Date :
Jan 16, 2034

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A: VRd+Rd (Standard Therapy)

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 25 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.

Drug: Bortezomib
Bortezomib will be administered SC.

Drug: Dexamethasone
Dexamethasone will be administered orally.

Drug: Lenalidomide
Lenalidomide will be administered orally.

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

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).

Drug: Bortezomib
Bortezomib will be administered SC.

Drug: Dexamethasone
Dexamethasone will be administered orally.

Drug: Lenalidomide
Lenalidomide will be administered orally.

Drug: Cilta-cel
Cilta-cel infusion will be administered.
Other Names:
  • JNJ-68284528
  • Drug: Cyclophosphamide
    Cyclophosphamide will be administered intravenously.

    Drug: Fludarabine
    Fludarabine will be administered intravenously.

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Up to 4 years and 5 months]

      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

    1. Sustained Minimal Residual Disease (MRD) Negative CR [Up to 12 years and 5 months]

      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.

    2. MRD Negative CR at 9 Months [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.

    3. Overall MRD Negative CR [Up to 12 years and 5 months]

      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.

    4. Overall Survival (OS) [Up to 12 years and 5 months]

      Overall survival is measured from the date of randomization to the date of the participant's death.

    5. Complete Response or Better [Up to 12 years and 5 months]

      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.

    6. Time to Subsequent Anti-myeloma Therapy [Up to 12 years and 5 months]

      Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.

    7. Progression Free Survival on Next-line Therapy (PFS2) [Up to 12 years and 5 months]

      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.

    8. Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs [Up to 12 years and 5 months]

      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.

    9. Arm B: Systemic Cytokine Concentrations [Up to Day 112]

      Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.

    10. Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers [Up to 12 years and 5 months]

      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.

    11. Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA) [Up to 1 year]

      Levels of soluble BCMA will be reported.

    12. Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence [Up to 12 years and 5 months]

      Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.

    13. Arm B: Number of Participants with Anti-cilta-cel Antibodies [Up to 12 years and 5 months]

      Number of participants with anti-cilta-cel antibodies will be reported.

    14. Arm B: Number of Participants with Presence of Replication Competent Lentivirus [Up to 12 years and 5 months]

      Number of participants with presence of replication competent lentivirus will be reported.

    15. 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 [Baseline up to 12 years and 5 months]

      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.

    16. Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score [Baseline up to 12 years and 5 months]

      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.

    17. 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 [Baseline up to 12 years and 5 months]

      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).

    18. Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score [Baseline up to 12 years and 5 months]

      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).

    19. Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items [Up to 161 days]

      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.

    20. Time to Worsening of Symptoms, Functioning and Overall Well-being [Up to 12 year and 5 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 *109/L; absolute lymphocyte count >=0.3 *109/L; absolute neutrophil count (ANC) >=1.0 ×109/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 m2) 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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1UCSFSan FranciscoCaliforniaUnited States94143
    2Stanford University Medical CenterStanfordCaliforniaUnited States94305-5623
    3Yale Cancer CenterNew HavenConnecticutUnited States06510
    4University of Miami Health SystemMiamiFloridaUnited States33136
    5AdventHealth Cancer InstituteOrlandoFloridaUnited States32832
    6University of Iowa Hospitals & ClinicsIowa CityIowaUnited States52242
    7University of Kansas Medical CenterWestwoodKansasUnited States66205
    8University of KentuckyLexingtonKentuckyUnited States40536-0293
    9Norton Cancer InstituteLouisvilleKentuckyUnited States40207
    10University Of Maryland Medical CenterBaltimoreMarylandUnited States21201-1595
    11Harvard Medical School-Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States02215-5450
    12Dana Farber Cancer InstituteBostonMassachusettsUnited States02215
    13Massachusetts General HospitalBostonMassachusettsUnited States02215
    14Barbara Ann Karmanos Cancer InstituteDetroitMichiganUnited States48201
    15Henry Ford Cancer InstituteDetroitMichiganUnited States48202-2608
    16Mayo Clinic - RochesterRochesterMinnesotaUnited States55905
    17Columbia University Medical CenterNew YorkNew YorkUnited States10032
    18Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States10065
    19University of North CarolinaChapel HillNorth CarolinaUnited States27599
    20Levine Cancer InstituteCharlotteNorth CarolinaUnited States28204
    21Thomas Jefferson UniversityPhiladelphiaPennsylvaniaUnited States19107
    22University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15232
    23University of Texas Southwestern Medical CenterDallasTexasUnited States75390-8562
    24University of VirginiaCharlottesvilleVirginiaUnited States22903
    25Medical College Of WisconsinMilwaukeeWisconsinUnited States53226
    26Hospital AlemanBuenos AiresArgentinaC1118AAT
    27Hospital Italiano de Buenos AiresBuenos AiresArgentinaC1199ABD
    28Hospital Privado Universitario de CórdobaCordobaArgentina5016
    29Hospital Universitario AustralPilarArgentina1629
    30Royal Prince Alfred HospitalCamperdownAustralia2050
    31St. Vincent's Hospital MelbourneFitzroyAustralia3065
    32Austin HealthHeidelbergAustralia3084
    33Royal Brisbane and Womens HospitalHerstonAustralia4029
    34Alfred HealthMelbourneAustralia3004
    35Peter MacCallum Cancer CentreMelbourneAustralia8006
    36Fiona Stanley HospitalMurdochAustralia6150
    37Calvary Mater Newcastle HospitalWaratahAustralia2298
    38Western Sydney Local Health DistrictWestmeadAustralia2145
    39Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für HämatologieGrazAustria8036
    40Krankenhaus der Elisabethinen LinzLinzAustria4020
    41LKH - Universitätsklinikum der PMU SalzburgSalzburgAustria5020
    42Medical University of Vienna,Universitätsklinik für Innere Medizin IViennaAustria1090
    43Universitair Ziekenhuis - AntwerpenAntwerpBelgium2650
    44AZ St.-Jan Brugge-Oostende AVBruggeBelgium8000
    45Cliniques Universitaires St-LucBrusselBelgium1200
    46UZ GentGentBelgium9000
    47UZ LeuvenLeuvenBelgium3000
    48Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart TilmanLiegeBelgiumB-4000
    49Hospital Sao RafaelSalvadorBrazil41253-190
    50Ac Camargo Cancer CenterSão PauloBrazil01509-010
    51Hospital Israelita Albert EinsteinSão PauloBrazil05652-900
    52Tom Baker Cancer CentreCalgaryAlbertaCanadaT2N 4N2
    53Juravinski Cancer CentreHamiltonOntarioCanadaL8V5C2
    54Princess Margaret Cancer Centre University Health NetworkTorontoOntarioCanadaM5G2M9
    55Hopital Maisonneuve-RosemontMontréalQuebecCanadaH1T 2M4
    56Vancouver General HospitalVancouverCanadaV5Z 1M9
    57Fakultni nemocnice BrnoBrnoCzechia625 00
    58Fakultni nemocnice Hradec KraloveHradec KraloveCzechia500 05
    59Fakultni nemocnice OstravaOstravaCzechia70852
    60Fakultni nemocnice PlzenPlzen-LochotinCzechia304 60
    61Vseobecna fakultni nemocnice v PrazePraha 2Czechia128 08
    62Aarhus University HospitalAarhus CDenmark8000
    63RigshospitaletCopenhagenDenmark2100
    64Odense UniversitetshospitalOdense CDenmark5000
    65Helsinki University HospitalHelsinkiFinland00029 HUS
    66Oulu University HospitalOuluFinland90220
    67Turku University HospitalTurkuFinland20520
    68Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude HuriezLille CedexFrance59000
    69C.H.U. Hotel Dieu - FranceNantesFrance44093
    70Hopital Saint-LouisParis cedex 10France75475
    71CHU Poitiers - Hôpital la MilétriePoitiersFrance86021
    72Institut Universitaire du cancer de Toulouse-OncopoleToulouse cedex 9France31059
    73Charité - Universitätsmedizin Berlin, Campus Benjamin FranklinBerlinGermany12203
    74Universitaetsklinikum Carl Gustav Carus TU DresdenDresdenGermany01307
    75Universitatsklinikum FreiburgFreiburgGermany79106
    76Universitaetsklinikum Hamburg EppendorfHamburgGermany20246
    77Medizinische Hochschule HannoverHannoverGermany30625
    78Universitaetsklinikum HeidelbergHeidelbergGermany69120
    79Universitatsklinikum LeipzigLeipzigGermany04103
    80Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-GermanyTübingenGermany72076
    81Universitätsklinikum WürzburgWürzburgGermany97080
    82Attikon University General Hospital of AtticaAthensGreece12462
    83G.PapanikolaouThessalonikiGreece57010
    84Debreceni Egyetem Klinikai KozpontDebrecenHungary4032
    85St James's HospitalDublinIrelandD08 NHY1
    86Hadassah University Hospita - Ein KeremJerusalemIsraelP.O.B. 12000
    87Sheba Medical Center Tel HashomerRamat GanIsrael52621
    88Tel Aviv Sourasky Medical CenterTel AvivIsrael64239
    89A.O. Universitaria Ospedali Riuniti di AnconaAnconaItaly60020
    90Azienda Ospedaliera Papa Giovanni XXIIIBergamoItaly24127
    91Policlinico Sant'Orsola MalpighiBolognaItaly40138
    92IRCCS Azienda Ospedaliera San Martino - ISTGenovaItaly16132
    93Fondazione IRCCS Istituto Nazionale dei TumoriMilanoItaly20133
    94ASST Grande Ospedale Metropolitano NiguardaMilanoItaly20162
    95Casa di Cura La MaddalenaPalermoItaly90146
    96Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio CalabriaReggio CalabriaItaly89133
    97AOU Policlinico Umberto IRomaItaly00161
    98Azienda Ospedaliera Universitaria Integrata VeronaVeronaItaly37134
    99Kyushu University HospitalFukuokaJapan812-8582
    100Kanazawa University HospitalKanazawaJapan920-8641
    101University Hospital Kyoto Perfectural University of MedicineKyotoJapan602-8566
    102Nagoya City University HospitalNagoyaJapan467-8602
    103Okayama University HospitalOkayamaJapan700-8558
    104Hokkaido University HospitalSapporoJapan060-8648
    105Tohoku University HospitalSendaiJapan980-8574
    106Japanese Red Cross Medical CenterShibuyaJapan150-8935
    107Chonnam National University Hwasun HospitalHwasun GunKorea, Republic of58128
    108Seoul National University HospitalSeoulKorea, Republic of03080
    109Severance Hospital, Yonsei University Health SystemSeoulKorea, Republic of03722
    110Asan Medical CenterSeoulKorea, Republic of05505
    111Samsung Medical CenterSeoulKorea, Republic of06351
    112The Catholic University of Korea, Seoul St. Mary's HospitalSeoulKorea, Republic of06591
    113VU Medisch CentrumAmsterdamNetherlands1081 HV
    114University Medical Center GroningenGroningenNetherlands9713 GZ
    115UMC RadboudNijmegenNetherlands6500 HB
    116Erasmus MCRotterdamNetherlands3075 EA
    117Oslo universitetssykehus HF, RikshospitaletOsloNorway0372
    118Uniwersyteckie Centrum KliniczneGdanskPoland80-214
    119Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w GliwicachGliwicePoland44102
    120Centrum Onkologii Ziemi Lubelskiej im. św. Jana z DukliLublinPoland20-090
    121Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola MarcinkowskiegoPoznanPoland60-569
    122Instytut Hematologii i TransfuzjologiiWarszawaPoland02-776
    123Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuWroclawPoland50-367
    124Instituto Portugues de OncologiaLisboaPortugal1099-023
    125Hospital De Santa MariaLisboaPortugal1649-035
    126Instituto Portugues de OncologiaPortoPortugal4200072
    127Hosp. de La Santa Creu I Sant PauBarcelonaSpain08041
    128Hosp. Univ. Vall D HebronBarcelonaSpain8035
    129Instituto Catalan Deoncologia Hospital Duran I ReynalsL'Hospitalet de LlobregatSpain08908
    130Hosp. Gral. Univ. Gregorio MarañonMadridSpain28007
    131Hosp. Univ. 12 de OctubreMadridSpain28041
    132Hosp. Univ. Virgen de La ArrixacaMurciaSpain30120
    133Clinica Univ. de NavarraPamplonaSpain31008
    134Hosp. Clinico Univ. de SalamancaSalamancaSpain37007
    135Hosp. Univ. Marques de ValdecillaSantanderSpain39008
    136Hosp. Virgen Del RocioSevillaSpain41013
    137Hosp. Univ. I Politecni La FeValenciaSpain46026
    138Sahlgrenska University HospitalGöteborgSweden413 45
    139UniversitetssjukhusetLinköpingSweden58185
    140Skane University HospitalLundSweden221 85
    141Haematology Centre, R 51StockholmSwedenSE-141 86
    142Akademiska SjukhusetUppsalaSweden751 85
    143Universitatsspital BaselBaselSwitzerland4031
    144INSELSPITAL, Universitätsspital BernBernSwitzerland3010
    145Kantonsspital St.GallenSt. GallenSwitzerland9007
    146UniversitaetsSpital ZuerichZürichSwitzerland
    147University Hospitals Birmingham NHS Trust,BirminghamUnited KingdomB15 2TH
    148Bristol Royal InfirmaryBristolUnited KingdomBS2 8BJ
    149Leeds Teaching Hospitals NHS TrustLeeds,United KingdomLS9 7TF
    150University College HospitalLondonUnited KingdomNW1 2BU
    151King's College HospitalLondonUnited KingdomSE5 9RS
    152Manchester Royal InfirmaryManchesterUnited KingdomM13 9WL
    153The Royal Marsden NHS Trust SuttonSurreyUnited KingdomSM2 5PT

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04923893
    Other Study ID Numbers:
    • CR109015
    • 2021-001242-35
    • 68284528MMY3004
    First Posted:
    Jun 11, 2021
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Janssen Research & Development, LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 25, 2022