A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03652064
Collaborator
(none)
395
Enrollment
114
Locations
2
Arms
77.8
Anticipated Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.

Detailed Description

This study will evaluate participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. The data available from other available studies suggests that addition of daratumumab with Velcade (bortezomib), lenalidomide, and dexamethasone [VRd] is anticipated to improve the response rates and the depth of response and may lead to improved long-term outcomes in newly diagnosed participants with MM. Daratumumab targets CD38, a protein expressed on the surface of MM cells and other hematopoietic cells. Bortezomib is a proteasome inhibitor, which plays a critical role in the pathogenesis of MM. Lenalidomide has cytotoxic effects on myeloma cells and is capable of inducing apoptosis, or programmed cell death and dexamethasone induces apoptosis in MM cells. The rationale for the study is to utilize the subcutaneous (SC) formulation of daratumumab instead of the intravenous (IV) formulation, which is expected to provide similar exposure and is expected to limit additional toxicity to participants, treated with this quadruplet regimen. The study will consist of 3 phases: Screening (up to 28 days before randomization), Treatment phase (from Cycle 1 [21 days] Day 1 and continues until disease progression) and Follow up (Postintervention). Efficacy evaluations will include measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations, skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. Participants will undergo procedures like electrocardiogram (ECG), chest x-rays or full dose chest CT scans, Pulmonary function test (PFT), spirometry etc. during the course of study. Participants will also be monitored closely for adverse events (AEs), laboratory abnormalities, and clinical response. The duration of the study will be approximately 6.5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
395 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Actual Study Start Date :
Nov 6, 2018
Actual Primary Completion Date :
Apr 8, 2021
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Bortezomib + Lenalidomide + Dexamethasone (VRd) and Rd

Participants will receive bortezomib 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 (cycle of 28 days); dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond (each cycle is of 28 days) followed by lenalidomide-dexamethasone (Rd) until disease progression or unacceptable toxicity.

Drug: Bortezomib
Bortezomib 1.3 mg/m^2 will be administered by SC injection twice weekly on Days 1, 4, 8, and 11 of each 21-day cycle for Cycles 1-8.
Other Names:
  • Velcade
  • Drug: Lenalidomide
    Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 and beyond until disease progression or unacceptable toxicity whichever occurs first.
    Other Names:
  • Revlimid
  • Drug: Dexamethasone
    Dexamethasone will be self-administered orally, 20 mg on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for Cycles 1-8. During Cycle 9 and beyond dexamethasone, will be self-administered orally at a total dose of 40 mg on Days 1, 8, 15, 22 of each 28-day cycle.

    Experimental: Daratumumab + VRd (D-VRd) and DRd

    Participants will receive daratumumab 1800 mg as SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3 through 8 and every 4 weeks for Cycle 9 and beyond; bortezomib 1.3 mg/m^2 as SC injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9; dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond followed by daratumumab-lenalidomide-dexamethasone (DRd) until disease progression or unacceptable toxicity.

    Drug: Daratumumab
    Daratumumab (1800 mg) will be administered by SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3-8. For Cycle 9 and beyond, participants will receive daratumumab 1800 mg SC once every 4 weeks until documented disease progression or unacceptable toxicity.
    Other Names:
  • JNJ-54767414
  • DARZALEX
  • Drug: Bortezomib
    Bortezomib 1.3 mg/m^2 will be administered by SC injection twice weekly on Days 1, 4, 8, and 11 of each 21-day cycle for Cycles 1-8.
    Other Names:
  • Velcade
  • Drug: Lenalidomide
    Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 and beyond until disease progression or unacceptable toxicity whichever occurs first.
    Other Names:
  • Revlimid
  • Drug: Dexamethasone
    Dexamethasone will be self-administered orally, 20 mg on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for Cycles 1-8. During Cycle 9 and beyond dexamethasone, will be self-administered orally at a total dose of 40 mg on Days 1, 8, 15, 22 of each 28-day cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Negative Minimal Residual Disease (MRD) Status [After randomization and prior to progressive disease (PD) or the start of subsequent anti-myeloma therapy approximately 2.5 years]

      Percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirates using next generation sequencing (NGS) at 10^-5 threshold will be assessed.

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) [From randomization to either disease progression or death whichever occurs first (approximately 6 years, or 9 years if the adaptive approach is decided at the interim)]

      PFS is defined as the duration from date of randomization to either PD or death, whichever comes first. International Myeloma Working Group (IMWG) criteria for PD: Increase of 25 percentage (%) from lowest response value in any one of following: Serum M-component (absolute increase must be >= 0.5 gram per deciliter [g/dL],) Urine M-component (absolute increase must be >=200 mg/24 hours), participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be >10 milligrams per deciliter [mg/dL]), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

    2. MRD Negative Rate [12,18 and 24 Months]

      Percentage of participants who have achieved MRD negative status will be assessed and landmark timepoints (12, 18 and 24 months). MRD negativity will be evaluated as a potential surrogate for PFS and overall survival (OS) in multiple myeloma treatment.

    3. Durable MRD Negative Rate [Throughout the study (approximately 6 year)]

      Durable MRD negativity rate is defined as the number of participants who have achieved MRD negative status (at 10^-5) at 2 bone marrow aspirates examinations that are a minimum of 1 year apart, without any examination showing MRD positive status in between.

    4. Overall Response Rate (ORR) [Up to the end of the study (approximately 6 years)]

      ORR is defined as the percentage of participants who achieve partial response (PR) or better responses prior to subsequent anti-myeloma therapy in accordance with IMWG criteria, during or after the study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90 % or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

    5. Very Good Partial Response (VGPR) or Better Rate [Approximately 6 years]

      VGPR or better rate is defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 % reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours); CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry.

    6. Complete Response (CR) or Better Rate [Approximately 6 years]

      CR or better rate is defined as the percentage of participants achieving CR or sCR prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment.

    7. PFS on the Next Line of Therapy [Time from randomization to progression on the next line of treatment or death, whichever comes first (up to approximately 6 years, or 9 years if the adaptive approach is decided at the interim)]

      The PFS on the next line of therapy is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first. Disease progression will be based on investigator judgment.

    8. Overall Survival (OS) [From randomization until the participant's death from any cause (up to approximately 6 years, or 9 years if the adaptive approach is decided at the interim)]

      OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

    9. Time to Response [From randomization until PR or better until approximately 6 years]

      Time to response is defined as the time between the randomization and the first efficacy evaluation at which the participant meets all criteria for PR or better.

    10. Duration of Response (DOR) [From initial documentation of response to the date of PD until approximately 6 years]

      DOR is calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD, as defined in the IMWG evaluation before the start of any subsequent anti-myeloma therapy.

    11. Maximum Observed Serum Concentration (Cmax) of Daratumumab [Predose Cycle 1, Day 1 (C1D1), C3D1, C9D1, C12D1, and post dose C1D4, C3D4, Post-treatment Week 8 (Cycle 1 to 8 is of 21 days; Cycle 9 and onwards are of 28 days)]

      The Cmax is the maximum observed serum concentration of daratumumab.

    12. Minimum Observed Serum Concentration (Cmin) of Daratumumab [Predose, C1D1 (each cycle of 28 days), C3D1, C9D1, C12D1, and post dose C1D4, C3D4, Post-treatment Week 8 (Cycle 1 to 8 is of 21 days; Cycle 9 and onwards are of 28 days)]

      The Cmin is the minimum observed serum concentration of daratumumab.

    13. Number of Participants with Anit-daratumumab Antibodies [Predose, C1D1 (each cycle of 28 days), C9D1, C12D1, Post-treatment Week 8 (Cycle 1 to 8 is of 21 days; Cycle 9 and onwards are of 28 days)]

      Number of participants with anti-daratumumab antibodies will be assessed.

    14. Number of Participants with Anit-rHuPH20 Antibodies [Predose, C1D1 (each cycle of 28 days), C9D1, C12D1, Post-treatment Week 8 (Cycle 1 to 8 is of 21 days; Cycle 9 and onwards are of 28 days)]

      Number of participants with anti-recombinant human hyaluronidase (rHuPH20) antibodies will be assessed.

    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 item (EORTC QLQ-C30) [Baseline, up to 6 years (end of study)]

      The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. 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 (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Multiple Myeloma 20-item (EORTC QLQ-MY20) [Baseline, up to 6 years (end of study)]

      The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).

    17. Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) [Baseline, up to 6 years (end of study)]

      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 plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.
    Biomarkers of Malignancy: Clonal bone marrow plasma cell percentage >=60%; Involved:

    uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies

    • Must have measurable disease, as assessed by central laboratory

    • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

    • A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing

    • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen

    Exclusion Criteria:
    • Frailty index of >=2 according to Myeloma Geriatric Assessment score

    • Prior therapy for multiple myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day, total of 160 mg dexamethasone or equivalent)

    • Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)

    • 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

    • Focal radiation therapy within 14 days of randomization with the exception of palliative radiotherapy for symptomatic pain management. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Innovative Clinical Research, Inc.WhittierCaliforniaUnited States90805
    2Baptist MD AndersonJacksonvilleFloridaUnited States32207
    3Fort Wayne Medical Oncology and Hematology, Inc.Fort WayneIndianaUnited States46804
    4Norton HealthcareLouisvilleKentuckyUnited States40207
    5Tufts Medical CenterBostonMassachusettsUnited States02111
    6Boston University Medical CenterBostonMassachusettsUnited States02118
    7Cancer & Hematology Centers of Western Michigan, PCGrand RapidsMichiganUnited States49503
    8Saint Luke's Hospital - Saint Luke's Cancer SpecialistsKansas CityMissouriUnited States64111
    9Rutgers Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States08903
    10San Juan Oncology AssociatesFarmingtonNew MexicoUnited States87401
    11Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
    12NYU WinthropMineolaNew YorkUnited States11501
    13Levine Cancer InstituteCharlotteNorth CarolinaUnited States28204
    14Cleveland ClinicClevelandOhioUnited States44195
    15Good Samaritan Hospital CorvallisCorvallisOregonUnited States97330
    16University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterPittsburghPennsylvaniaUnited States15232-1301
    17Gibbs Cancer CenterSpartanburgSouth CarolinaUnited States29303
    18University of Texas, MD Anderson Cancer CenterHoustonTexasUnited States77030
    19University of VirginiaCharlottesvilleVirginiaUnited States22908
    20Universidade Estadual De CampinasCampinasBrazil13083-878
    21Liga Norte Riograndense Contra O CancerNatalBrazil59062-000
    22Hospital São Lucas da PUCRSPorto AlegreBrazil90610-000
    23Instituto Nacional do Cancer - INCARio de JaneiroBrazil20230-130
    24Instituto COI de Pesquisa, Educacao e GestaoRio de JaneiroBrazil22793-080
    25Instituto de Ensino E Pesquisa Sao LucasSao PauloBrazil01236-030
    26IBCC Instituto Brasileiro de Controle do CancerSao PauloBrazil03102-002
    27Hospital Beneficencia PortuguesaSão PauloBrazil01323-010
    28Clinica Sao GermanoSão PauloBrazil01455-010
    29Hospital Santa CruzSão PauloBrazil04122-000
    30Tom Baker Cancer CentreCalgaryAlbertaCanadaT2N 4N2
    31Cross Cancer InstituteEdmontonAlbertaCanadaT6G 1Z2
    32The Gordon & Leslie Diamond Health Care CenterVancouverBritish ColumbiaCanadaV5Z 1M9
    33QEII Health Sciences CentreHalifaxNova ScotiaCanadaB3H 1V7
    34Victoria HospitalLondonOntarioCanadaN6A 5W9
    35Lakeridge Health OshawaOshawaOntarioCanadaL1G-2B9
    36McGill University Health CentreMontrealQuebecCanadaH4A 3J1
    37Brampton Civic HospitalBramptonCanadaL6R 3J7
    38CHU de Québec -L'Hôtel-Dieu de QuébecQuebecCanadaG1R 2J6
    39Fakultni nemocnice BrnoBrnoCzechia625 00
    40Fakultni nemocnice Hradec KraloveHradec KraloveCzechia500 05
    41Fakultni nemocnice OstravaOstravaCzechia708 52
    42Fakultni nemocnice Plzen, Hemato-onkologicke oddeleniPlzenCzechia304 60
    43Vseobecna fakultni nemocnice v PrazePraha 2Czechia128 08
    44CHU Henri MondorCreteil N/aFrance94010
    45Centre Hospitalier Départmental La Roche sur YonLa Roche sur Yon Cedex 9France85925
    46Hopital Claude HuriezLilleFrance59037
    47Institut Paoli CalmettesMarseille Cedex 9France13009
    48CHU de Montpellier, Hopital Saint-EloiMontpellierFrance34295
    49CHU de Bordeaux - Hôpital Haut-LévêquePessac cedexFrance33604
    50Strasbourg Oncologie LibéraleStrasbourgFrance67000
    51Institut Universitaire du cancer de Toulouse-OncopoleToulouse cedex 9France31059
    52phase 3 - Hämatoonkologischer Studienkreis am Klinikum AschaffenburgAschaffenburgGermany63739
    53Universitatsklinikum FreiburgFreiburgGermany79106
    54St. Josef-Krankenhaus Hamm-Bockum-HövelHammGermany59075
    55Institut für VersorgungsforschungKoblenzGermany56068
    56Universitatsmedizin LeipzigLeipzigGermany4103
    57Klinikum Großhadern der Ludwig-Maximilians-UniversitätMünchenGermany81377
    58Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,TuebingenGermany72076
    59Barzilai Medical CenterAshkelonIsrael78741
    60Hillel Yaffe Medical CenterHaderaIsrael38100
    61Rambam Med.Center - Hematology InstituteHaifaIsrael3109601
    62Carmel Medical CenterHaifaIsrael3436212
    63Meir HospitalKfar SabaIsrael44281
    64Rabin Medical CenterPetah-TiqvaIsrael49100
    65Sheba Medical CenterRamat GanIsrael52621
    66Sourasky (Ichilov) Medical CenterTel AvivIsrael64239
    67Fukuoka University HospitalFukuokaJapan814-0180
    68Ogaki Municipal HospitalGifuJapan503-8502
    69Kobe City Medical Center General HospitalHyogoJapan650-0047
    70Kanazawa University HospitalKanazawaJapan920-8641
    71National Hospital Organization Kumamoto Medical CenterKumamotoJapan860-0008
    72University Hospital Kyoto Perfectural University of MedicineKyotoJapan602-8566
    73National Hospital Organization Matsumoto Medical CenterMatsumotoJapan399-8701
    74Matsuyama Red Cross HospitalMatsuyamaJapan790-8524
    75Nagoya City University HospitalNagoyaJapan467-8602
    76National Hospital Organization Okayama Medical CenterOkayamaJapan701-1192
    77Japanese Red Cross Osaka HospitalOsakaJapan543-8555
    78National Hospital Organization Shibukawa Medical CenterShibukawaJapan377-0280
    79Japanese Red Cross Medical CenterShibuyaJapan150-8935
    80VU Medisch CentrumAmsterdamNetherlands1081 HV
    81Albert Schweitzer ziekenhuis-lokatie DordwijkDordrechtNetherlands3318 AT
    82Erasmus MCRotterdamNetherlands3015CE
    83Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. MarkiewiczaBrzozowPoland36-200
    84Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali MiejskichChorzówPoland41-500
    85Uniwersyteckie Centrum MedyczneGdanskPoland80-214
    86Swietokrzyskie Centrum Onkologii SPZOZ w KielcachKielcePoland25-734
    87Szpital Uniwersytecki w KrakowieKrakowPoland30-501
    88Centrum Onkologii Ziemi Lubelskiej im. św. Jana z DukliLublinPoland20090
    89Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola MarcinkowskiegoPoznanPoland60-569
    90Wojewodzki Szpital Specjalistyczny im. Janusza KorczakaSlupskPoland76-200
    91Instytut Hematologii i TransfuzjologiiWarszawaPoland02-776
    92Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyWarszawaPoland02-781
    93Hosp. Univ. Fundacion AlcorconAlcorconSpain28922
    94Hosp. Del MarBarcelonaSpain08003
    95Hosp. Univ. de GuadalajaraGuadalajaraSpain19002
    96Hosp. Univ. Pta. de Hierro MajadahondaMajadahondaSpain28222
    97Hosp. Quiron Madrid PozueloPozuelo De Alarcon, MadridSpain28223
    98Hosp. Mutua TerrassaTerrassaSpain08221
    99Gulhane Egitim ve Arastirma HastanesiAnkaraTurkey06010
    100Hacettepe University Medical FacultyAnkaraTurkey06100
    101Dr.Abdurrahman Yurtaslan Oncology Training and Research HospitalAnkaraTurkey06200
    102Ankara University School of Medicine, Cebeci HospitalAnkaraTurkey06590
    103Istanbul University Istanbul Medical FacultyIstanbulTurkey34093
    104Dokuz Eylul University Medical FacultyIzmirTurkey35340
    105Ondokuz Mayis Universitesi Tip FakultesiSamsunTurkey55280
    106Monklands District General HospitalAirdrieUnited KingdomML6 0JS
    107Blackpool Victoria HospitalBlackpoolUnited KingdomFY3 8NR
    108University Hospital WalesCardiffUnited KingdomCF14 4XN
    109Colchester Hospital University NHSColchesterUnited KingdomCO4 5JL
    110Leicester Royal Infirmary - HaematologyLeicesterUnited KingdomLE1 5WW
    111Altnagelvin HospitalLondonderryUnited KingdomBT47 6SB
    112North Manchester General HospitalManchesterUnited KingdomM8 6RL
    113Derriford HospitalPlymouthUnited KingdomPL6 8DH
    114New Cross HospitalWolverhamptonUnited KingdomWV10 0QP

    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:
    NCT03652064
    Other Study ID Numbers:
    • CR108529
    • 2018-001545-13
    • 54767414MMY3019
    First Posted:
    Aug 29, 2018
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021