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
156
2
149.1
4.2
0

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 20, 2034

Arms and Interventions

Arm Intervention/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

    Site City State Country Postal Code
    1 UCSF San Francisco California United States 94143
    2 Stanford University Medical Center Stanford California United States 94305-5623
    3 Yale Cancer Center New Haven Connecticut United States 06510
    4 University of Miami Health System Miami Florida United States 33136
    5 AdventHealth Cancer Institute Orlando Florida United States 32832
    6 Loyola University Medical Center Melrose Park Illinois United States 60160
    7 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    8 University of Kansas Medical Center Westwood Kansas United States 66205
    9 University of Kentucky Lexington Kentucky United States 40536-0293
    10 Norton Cancer Institute Louisville Kentucky United States 40207
    11 University Of Maryland Medical Center Baltimore Maryland United States 21201-1595
    12 Harvard Medical School-Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215-5450
    13 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    14 Massachusetts General Hospital Boston Massachusetts United States 02215
    15 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    16 Henry Ford Cancer Institute Detroit Michigan United States 48202-2608
    17 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    18 Columbia University Medical Center New York New York United States 10032
    19 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
    20 University of North Carolina Chapel Hill North Carolina United States 27599
    21 Levine Cancer Institute Charlotte North Carolina United States 28204
    22 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    23 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    24 University of Texas Southwestern Medical Center Dallas Texas United States 75390-8562
    25 University of Virginia Charlottesville Virginia United States 22903
    26 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226
    27 Hospital Aleman Buenos Aires Argentina C1118AAT
    28 Hospital Italiano de Buenos Aires Buenos Aires Argentina C1199ABD
    29 Hospital Privado Centro Medico de Cordoba Cordoba Argentina X5016KEH
    30 Hospital Universitario Austral Pilar Argentina 1629
    31 Royal Prince Alfred Hospital Camperdown Australia 2050
    32 St. Vincent's Hospital Melbourne Fitzroy Australia 3065
    33 Austin Health Heidelberg Australia 3084
    34 Royal Brisbane and Womens Hospital Herston Australia 4029
    35 Alfred Health Melbourne Australia 3004
    36 Peter MacCallum Cancer Centre Melbourne Australia 8006
    37 Fiona Stanley Hospital Murdoch Australia 6150
    38 Calvary Mater Newcastle Hospital Waratah Australia 2298
    39 Western Sydney Local Health District Westmead Australia 2145
    40 Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie Graz Austria 8036
    41 Medizinische Universitatsklinik Innsbruck Innsbruck Austria 6020
    42 Krankenhaus der Elisabethinen Linz Linz Austria 4020
    43 LKH - Universitätsklinikum der PMU Salzburg Salzburg Austria 5020
    44 Medical University of Vienna,Universitätsklinik für Innere Medizin I Vienna Austria 1090
    45 Universitair Ziekenhuis - Antwerpen Antwerp Belgium 2650
    46 AZ St.-Jan Brugge-Oostende AV Brugge Belgium 8000
    47 Cliniques Universitaires St-Luc Brussel Belgium 1200
    48 UZ Gent Gent Belgium 9000
    49 UZ Leuven Leuven Belgium 3000
    50 Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman Liege Belgium B-4000
    51 Hospital Sao Rafael Salvador Brazil 41253-190
    52 Ac Camargo Cancer Center Sao Paulo Brazil 01509-010
    53 Hospital Israelita Albert Einstein São Paulo Brazil 05652-900
    54 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    55 Juravinski Cancer Centre Hamilton Ontario Canada L8V5C2
    56 Princess Margaret Cancer Centre University Health Network Toronto Ontario Canada M5G2M9
    57 Hopital Maisonneuve-Rosemont Montréal Quebec Canada H1T 2M4
    58 Vancouver General Hospital Vancouver Canada V5Z 1M9
    59 Fakultni nemocnice Brno Brno Czechia 625 00
    60 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    61 Fakultni nemocnice Ostrava Ostrava Czechia 70852
    62 Fakultni nemocnice Plzen Plzen-Lochotin Czechia 304 60
    63 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 128 08
    64 Aarhus University Hospital Aarhus C Denmark 8000
    65 Rigshospitalet Copenhagen Denmark 2100
    66 Odense Universitetshospital Odense C Denmark 5000
    67 Helsinki University Hospital Helsinki Finland 00029 HUS
    68 Oulu University Hospital Oulu Finland 90220
    69 Turku University Hospital Turku Finland 20520
    70 Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez Lille Cedex France 59000
    71 C.H.U. Hotel Dieu - France Nantes France 44093
    72 Hopital Saint-Louis Paris cedex 10 France 75475
    73 CHU Poitiers - Hôpital la Milétrie Poitiers France 86021
    74 Institut Universitaire du cancer de Toulouse-Oncopole Toulouse cedex 9 France 31059
    75 Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin Berlin Germany 12203
    76 Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden Germany 01307
    77 Universitatsklinikum Freiburg Freiburg Germany 79106
    78 Universitaetsklinikum Hamburg Eppendorf Hamburg Germany 20246
    79 Medizinische Hochschule Hannover Hannover Germany 30625
    80 Universitaetsklinikum Heidelberg Heidelberg Germany 69120
    81 Universitatsklinikum Leipzig Leipzig Germany 04103
    82 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    83 Universitaetsklinikum Regensburg Regensburg Germany 93053
    84 Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany Tübingen Germany 72076
    85 Universitätsklinikum Würzburg Würzburg Germany 97080
    86 Attikon University General Hospital of Attica Athens Greece 12462
    87 G.Papanikolaou Thessaloniki Greece 57010
    88 St James's Hospital Dublin Ireland D08 NHY1
    89 Hadassah University Hospita - Ein Kerem Jerusalem Israel P.O.B. 12000
    90 Sheba Medical Center Tel Hashomer Ramat Gan Israel 52621
    91 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    92 A.O. Universitaria Ospedali Riuniti di Ancona Ancona Italy 60020
    93 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24127
    94 Policlinico Sant'Orsola Malpighi Bologna Italy 40138
    95 IRCCS Azienda Ospedaliera San Martino - IST Genova Italy 16132
    96 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    97 ASST Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    98 Casa di Cura La Maddalena Palermo Italy 90146
    99 Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria Reggio Calabria Italy 89133
    100 AOU Policlinico Umberto I Roma Italy 00161
    101 Azienda Ospedaliera Universitaria Integrata Verona Verona Italy 37134
    102 Kyushu University Hospital Fukuoka Japan 812-8582
    103 Kanazawa University Hospital Kanazawa Japan 920-8641
    104 University Hospital Kyoto Perfectural University of Medicine Kyoto Japan 602-8566
    105 Nagoya City University Hospital Nagoya Japan 467-8602
    106 Okayama University Hospital Okayama Japan 700-8558
    107 Hokkaido University Hospital Sapporo Japan 060-8648
    108 Tohoku University Hospital Sendai Japan 980-8574
    109 Japanese Red Cross Medical Center Shibuya Japan 150-8935
    110 Chonnam National University Hwasun Hospital Jeollanam-do Korea, Republic of 58128
    111 Seoul National University Hospital Seoul Korea, Republic of 03080
    112 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    113 Asan Medical Center Seoul Korea, Republic of 05505
    114 Samsung Medical Center Seoul Korea, Republic of 06351
    115 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    116 VU Medisch Centrum Amsterdam Netherlands 1081 HV
    117 University Medical Center Groningen Groningen Netherlands 9713 GZ
    118 UMC Radboud Nijmegen Netherlands 6500 HB
    119 Erasmus MC Rotterdam Netherlands 3075 EA
    120 Oslo universitetssykehus HF, Rikshospitalet Oslo Norway 0372
    121 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-214
    122 Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach Gliwice Poland 44102
    123 Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli Lublin Poland 20-090
    124 Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu Poznań Poland 60-569
    125 Instytut Hematologii i Transfuzjologii Warszawa Poland 02-776
    126 Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw Poland 50-367
    127 Instituto Portugues de Oncologia Lisboa Portugal 1099-023
    128 Hospital De Santa Maria Lisboa Portugal 1649-035
    129 Instituto Portugues de Oncologia Porto Portugal 4200072
    130 Hosp. de La Santa Creu I Sant Pau Barcelona Spain 08041
    131 Hosp. Univ. Vall D Hebron Barcelona Spain 8035
    132 Instituto Catalan Deoncologia Hospital Duran I Reynals L'Hospitalet de Llobregat Spain 08908
    133 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28007
    134 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    135 Hosp. Univ. Virgen de La Arrixaca Murcia Spain 30120
    136 Clinica Univ. de Navarra Pamplona Spain 31008
    137 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007
    138 Hosp. Univ. Marques de Valdecilla Santander Spain 39008
    139 Hosp. Virgen Del Rocio Sevilla Spain 41013
    140 Hosp. Univ. I Politecni La Fe Valencia Spain 46026
    141 Sahlgrenska University Hospital Göteborg Sweden 413 45
    142 Universitetssjukhuset Linköping Sweden 58185
    143 Skane University Hospital Lund Sweden 221 85
    144 Haematology Centre, R 51 Stockholm Sweden SE-141 86
    145 Akademiska Sjukhuset Uppsala Sweden 751 85
    146 Universitatsspital Basel Basel Switzerland 4031
    147 INSELSPITAL, Universitätsspital Bern Bern Switzerland 3010
    148 Kantonsspital St.Gallen St. Gallen Switzerland 9007
    149 UniversitaetsSpital Zuerich Zürich Switzerland
    150 University Hospitals Birmingham NHS Trust, Birmingham United Kingdom B15 2TH
    151 Bristol Royal Infirmary Bristol United Kingdom BS2 8BJ
    152 Leeds Teaching Hospitals NHS Trust Leeds, United Kingdom LS9 7TF
    153 University College Hospital London United Kingdom NW1 2BU
    154 King's College Hospital London United Kingdom SE5 9RS
    155 Manchester Royal Infirmary Manchester United Kingdom M13 9WL
    156 The Royal Marsden NHS Trust Sutton Surrey United Kingdom SM2 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

    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:
    Aug 12, 2022
    Last Verified:
    Aug 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 Aug 12, 2022