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
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).
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|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.
Bortezomib will be administered SC.
Dexamethasone will be administered orally.
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).
Bortezomib will be administered SC.
Dexamethasone will be administered orally.
Lenalidomide will be administered orally.
Cilta-cel infusion will be administered.
Cyclophosphamide will be administered intravenously.
Fludarabine will be administered intravenously.
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 or cytometry by time of flight (CyTOF) or both and correlated with response.
- Arm B: Level of Soluble B-cell Maturation Antigen (BCMA) and BCMA Expressing Cells [Up to 1 year]
Level of soluble BCMA and BCMA expressing cells will be reported.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
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 (beta-human chorionic gonadotropin) tests prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd). The first test must be within 10 to 14 days prior to the start of VRd
Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than (>)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)
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 defined as (anti-hepatitis C virus [HCV] antibody positive or detectable HCV- ribonucleic acid [RNA]) or known to have a history of hepatitis C
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
|1||UCSF||San Francisco||California||United States||94143|
|2||Stanford University Medical Center||Stanford||California||United States||94305-5623|
|3||Advent Health Cancer Institute||Orlando||Florida||United States||32832|
|4||University of Iowa Hospitals & Clinics||Iowa City||Iowa||United States||52242|
|5||University of Kentucky||Lexington||Kentucky||United States||40536-0293|
|6||Norton Cancer Institute||Louisville||Kentucky||United States||40207|
|7||Harvard Medical School-Beth Israel Deaconess Medical Center||Boston||Massachusetts||United States||02215-5450|
|8||Dana Farber Cancer Institute||Boston||Massachusetts||United States||02215|
|9||Massachusetts General Hospital||Boston||Massachusetts||United States||02215|
|10||Barbara Ann Karmanos Cancer Institute||Detroit||Michigan||United States||48201|
|11||Henry Ford Cancer Institute||Detroit||Michigan||United States||48202-2608|
|12||Mayo Clinic - Rochester||Rochester||Minnesota||United States||55905|
|13||Columbia University Medical Center||New York||New York||United States||10032|
|14||Memorial Sloan-Kettering Cancer Center||New York||New York||United States||10065|
|15||University of North Carolina||Chapel Hill||North Carolina||United States||27599|
|16||Levine Cancer Institute||Charlotte||North Carolina||United States||28204|
|17||Thomas Jefferson University||Philadelphia||Pennsylvania||United States||19107|
|18||University of Pittsburgh Medical Center||Pittsburgh||Pennsylvania||United States||15232|
|19||University of Texas Southwestern Medical Center||Dallas||Texas||United States||75390-8562|
|20||Medical College Of Wisconsin||Milwaukee||Wisconsin||United States||53226|
|21||Hospital Aleman||Buenos Aires||Argentina||C1118AAT|
|22||Hospital Italiano de Buenos Aires||Buenos Aires||Argentina||C1199ABD|
|23||Hospital Privado Universitario de Córdoba||Cordoba||Argentina||5016|
|24||Hospital Universitario Austral||Pilar||Argentina||1629|
|25||Royal Prince Alfred Hospital||Camperdown||Australia||2050|
|26||St. Vincent's Hospital Melbourne||Fitzroy||Australia||3065|
|28||Royal Brisbane and Womens Hospital||Herston||Australia||4029|
|30||Peter MacCallum Cancer Centre||Melbourne||Australia||8006|
|31||Fiona Stanley Hospital||Murdoch||Australia||6150|
|32||Calvary Mater Newcastle Hospital||Waratah||Australia||2298|
|33||Western Sydney Local Health District||Westmead||Australia||2145|
|34||Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie||Graz||Austria||8036|
|35||Krankenhaus der Elisabethinen Linz||Linz||Austria||4020|
|36||LKH - Universitätsklinikum der PMU Salzburg||Salzburg||Austria||5020|
|37||Medical University of Vienna,Universitätsklinik für Innere Medizin I||Vienna||Austria||1090|
|38||Universitair Ziekenhuis - Antwerpen||Antwerp||Belgium||2650|
|39||AZ St.-Jan Brugge-Oostende AV||Brugge||Belgium||8000|
|40||Cliniques Universitaires St-Luc||Brussel||Belgium||1200|
|43||Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman||Liege||Belgium||B-4000|
|44||Hospital Sao Rafael||Salvador||Brazil||41253-190|
|45||Ac Camargo Cancer Center||São Paulo||Brazil||01509-010|
|46||Hospital Israelita Albert Einstein||São Paulo||Brazil||05652-900|
|47||Juravinski Cancer Centre||Hamilton||Ontario||Canada||L8V5C2|
|48||Princess Margaret Cancer Centre University Health Network||Toronto||Ontario||Canada||M5G2M9|
|49||Hopital Maisonneuve-Rosemont||Montréal||Quebec||Canada||H1T 2M4|
|50||Foothills Hospital||Calgary||Canada||T2N 2T9|
|51||Vancouver General Hospital||Vancouver||Canada||V5Z 1M9|
|52||Fakultni nemocnice Brno||Brno||Czechia||625 00|
|53||Fakultni nemocnice Hradec Kralove||Hradec Kralove||Czechia||500 05|
|54||Fakultni nemocnice Ostrava||Ostrava||Czechia||70852|
|55||Fakultni nemocnice Plzen||Plzen-Lochotin||Czechia||304 60|
|56||Vseobecna fakultni nemocnice v Praze||Praha 2||Czechia||128 08|
|57||Aarhus University Hospital||Aarhus C||Denmark||8000|
|59||Odense Universitetshospital||Odense C||Denmark||5000|
|60||Helsinki University Hospital||Helsinki||Finland||00029 HUS|
|61||Oulu University Hospital||Oulu||Finland||90220|
|62||Turku University Hospital||Turku||Finland||20520|
|63||Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez||Lille Cedex||France||59000|
|64||C.H.U. Hotel Dieu - France||Nantes||France||44093|
|65||Hopital Saint-Louis||Paris cedex 10||France||75475|
|66||CHU Poitiers - Hôpital la Milétrie||Poitiers||France||86021|
|67||Institut Universitaire du cancer de Toulouse-Oncopole||Toulouse cedex 9||France||31059|
|68||Universitaetsklinikum Carl Gustav Carus TU Dresden||Dresden||Germany||01307|
|69||Universitaetsklinikum Hamburg Eppendorf||Hamburg||Germany||20246|
|72||Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany||Tübingen||Germany||72076|
|74||Attikon University General Hospital of Attica||Athens||Greece||12462|
|76||Hadassah University Hospita - Ein Kerem||Jerusalem||Israel||P.O.B. 12000|
|77||Sheba Medical Center Tel Hashomer||Ramat Gan||Israel||52621|
|78||Tel Aviv Sourasky Medical Center||Tel Aviv||Israel||64239|
|79||A.O. Universitaria Ospedali Riuniti di Ancona||Ancona||Italy||60020|
|80||Azienda Ospedaliera Papa Giovanni XXIII||Bergamo||Italy||24127|
|81||Policlinico Sant'Orsola Malpighi||Bologna||Italy||40138|
|82||IRCCS Azienda Ospedaliera San Martino - IST||Genova||Italy||16132|
|83||Fondazione IRCCS Istituto Nazionale dei Tumori||Milano||Italy||20133|
|84||ASST Grande Ospedale Metropolitano Niguarda||Milano||Italy||20162|
|85||Casa di Cura La Maddalena||Palermo||Italy||90146|
|86||Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria||Reggio Calabria||Italy||89133|
|87||AOU Policlinico Umberto I||Roma||Italy||00161|
|88||Azienda Ospedaliera Universitaria Integrata Verona||Verona||Italy||37134|
|89||Kyushu University Hospital||Fukuoka||Japan||812-8582|
|90||Kanazawa University Hospital||Kanazawa||Japan||920-8641|
|91||University Hospital Kyoto Perfectural University of Medicine||Kyoto||Japan||602-8566|
|92||Nagoya City University Hospital||Nagoya||Japan||467-8602|
|93||Okayama University Hospital||Okayama||Japan||700-8558|
|94||Hokkaido University Hospital||Sapporo||Japan||060-8648|
|95||Tohoku University Hospital||Sendai||Japan||980-8574|
|96||Japanese Red Cross Medical Center||Shibuya||Japan||150-8935|
|97||Chonnam National University Hwasun Hospital||Hwasun Gun||Korea, Republic of||58128|
|98||Seoul National University Hospital||Seoul||Korea, Republic of||03080|
|99||Severance Hospital, Yonsei University Health System||Seoul||Korea, Republic of||03722|
|100||Asan Medical Center||Seoul||Korea, Republic of||05505|
|101||Samsung Medical Center||Seoul||Korea, Republic of||06351|
|102||The Catholic University of Korea, Seoul St. Mary's Hospital||Seoul||Korea, Republic of||06591|
|103||VU Medisch Centrum||Amsterdam||Netherlands||1081 HV|
|104||University Medical Center Groningen||Groningen||Netherlands||9713 GZ|
|105||Erasmus MC||Rotterdam||Netherlands||3075 EA|
|106||Oslo universitetssykehus HF, Rikshospitalet||Oslo||Norway||0372|
|107||Uniwersyteckie Centrum Kliniczne||Gdansk||Poland||80-214|
|108||Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach||Gliwice||Poland||44102|
|109||Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego||Poznan||Poland||60-569|
|110||Instytut Hematologii i Transfuzjologii||Warszawa||Poland||02-776|
|111||Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu||Wroclaw||Poland||50-367|
|112||Instituto Portugues de Oncologia||Lisboa||Portugal||1099-023|
|113||Instituto Portugues de Oncologia||Porto||Portugal||4200072|
|114||Hosp. de La Santa Creu I Sant Pau||Barcelona||Spain||08041|
|115||Hosp. Univ. Vall D Hebron||Barcelona||Spain||8035|
|116||Instituto Catalan Deoncologia Hospital Duran I Reynals||L'Hospitalet de Llobregat||Spain||08908|
|117||Hosp. Gral. Univ. Gregorio Marañon||Madrid||Spain||28007|
|118||Hosp. Univ. 12 de Octubre||Madrid||Spain||28041|
|119||Hosp. Univ. Virgen de La Arrixaca||Murcia||Spain||30120|
|120||Clinica Univ. de Navarra||Pamplona||Spain||31008|
|121||Hosp. Clinico Univ. de Salamanca||Salamanca||Spain||37007|
|122||Hosp. Univ. Marques de Valdecilla||Santander||Spain||39008|
|123||Hosp. Virgen Del Rocio||Sevilla||Spain||41013|
|124||Hosp. Univ. I Politecni La Fe||Valencia||Spain||46026|
|125||Sahlgrenska University Hospital||Göteborg||Sweden||413 45|
|127||Skane University Hospital||Lund||Sweden||221 85|
|128||Haematology Centre, R 51||Stockholm||Sweden||SE-141 86|
|129||Akademiska Sjukhuset||Uppsala||Sweden||751 85|
|131||INSELSPITAL, Universitätsspital Bern||Bern||Switzerland||3010|
|132||Kantonsspital St.Gallen||St. Gallen||Switzerland||9007|
|134||University Hospitals Birmingham NHS Trust,||Birmingham||United Kingdom||B15 2TH|
|135||Bristol Royal Infirmary||Bristol||United Kingdom||BS2 8BJ|
|136||Leeds Teaching Hospitals NHS Trust||Leeds,||United Kingdom||LS9 7TF|
|137||University College Hospital||London||United Kingdom||NW1 2BU|
|138||King's College Hospital||London||United Kingdom||SE5 9RS|
|139||Manchester Royal Infirmary||Manchester||United Kingdom||M13 9WL|
|140||The Royal Marsden NHS Trust Sutton||Surrey||United Kingdom||SM2 5PT|
Sponsors and Collaborators
- Janssen Research & Development, LLC
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)None provided.