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
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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
Arms and Interventions
| Arm | Intervention/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:
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:
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:
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:
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:
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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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
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
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Must have measurable disease, as assessed by central laboratory
-
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
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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
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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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Innovative Clinical Research, Inc. | Whittier | California | United States | 90805 |
| 2 | Baptist MD Anderson | Jacksonville | Florida | United States | 32207 |
| 3 | Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | United States | 46804 |
| 4 | Norton Healthcare | Louisville | Kentucky | United States | 40207 |
| 5 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 6 | Boston University Medical Center | Boston | Massachusetts | United States | 02118 |
| 7 | Cancer & Hematology Centers of Western Michigan, PC | Grand Rapids | Michigan | United States | 49503 |
| 8 | Saint Luke's Hospital - Saint Luke's Cancer Specialists | Kansas City | Missouri | United States | 64111 |
| 9 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 10 | San Juan Oncology Associates | Farmington | New Mexico | United States | 87401 |
| 11 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 12 | NYU Winthrop | Mineola | New York | United States | 11501 |
| 13 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
| 14 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 15 | Good Samaritan Hospital Corvallis | Corvallis | Oregon | United States | 97330 |
| 16 | University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232-1301 |
| 17 | Gibbs Cancer Center | Spartanburg | South Carolina | United States | 29303 |
| 18 | University of Texas, MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 19 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 20 | Universidade Estadual De Campinas | Campinas | Brazil | 13083-878 | |
| 21 | Liga Norte Riograndense Contra O Cancer | Natal | Brazil | 59062-000 | |
| 22 | Hospital São Lucas da PUCRS | Porto Alegre | Brazil | 90610-000 | |
| 23 | Instituto Nacional do Cancer - INCA | Rio de Janeiro | Brazil | 20230-130 | |
| 24 | Instituto COI de Pesquisa, Educacao e Gestao | Rio de Janeiro | Brazil | 22793-080 | |
| 25 | Instituto de Ensino E Pesquisa Sao Lucas | Sao Paulo | Brazil | 01236-030 | |
| 26 | IBCC Instituto Brasileiro de Controle do Cancer | Sao Paulo | Brazil | 03102-002 | |
| 27 | Hospital Beneficencia Portuguesa | São Paulo | Brazil | 01323-010 | |
| 28 | Clinica Sao Germano | São Paulo | Brazil | 01455-010 | |
| 29 | Hospital Santa Cruz | São Paulo | Brazil | 04122-000 | |
| 30 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 31 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 32 | The Gordon & Leslie Diamond Health Care Center | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 33 | QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 34 | Brampton Civic Hospital | Brampton | Ontario | Canada | L6R 3J7 |
| 35 | Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
| 36 | Lakeridge Health Oshawa | Oshawa | Ontario | Canada | L1G-2B9 |
| 37 | McGill University Health Centre | Montreal | Quebec | Canada | H4A 3J1 |
| 38 | CHU de Québec -L'Hôtel-Dieu de Québec | Quebec | Canada | G1J 1Z4 | |
| 39 | Fakultni nemocnice Brno | Brno | Czechia | 625 00 | |
| 40 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
| 41 | Fakultni nemocnice Ostrava | Ostrava | Czechia | 708 52 | |
| 42 | Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni | Plzen | Czechia | 323 00 | |
| 43 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | 128 08 | |
| 44 | CHU Henri Mondor | Creteil N/a | France | 94010 | |
| 45 | Centre Hospitalier Départmental La Roche sur Yon | La Roche sur Yon Cedex 9 | France | 85925 | |
| 46 | Hopital Claude Huriez | Lille | France | 59037 | |
| 47 | Institut Paoli Calmettes | Marseille Cedex 9 | France | 13009 | |
| 48 | CHU de Montpellier, Hopital Saint-Eloi | Montpellier | France | 34295 | |
| 49 | CHU de Bordeaux - Hôpital Haut-Lévêque | Pessac cedex | France | 33604 | |
| 50 | Strasbourg Oncologie Libérale | Strasbourg | France | 67000 | |
| 51 | Institut Universitaire du cancer de Toulouse-Oncopole | Toulouse cedex 9 | France | 31059 | |
| 52 | phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg | Aschaffenburg | Germany | 63739 | |
| 53 | Universitatsklinikum Freiburg | Freiburg | Germany | 79106 | |
| 54 | St. Josef-Krankenhaus Hamm-Bockum-Hövel | Hamm | Germany | 59075 | |
| 55 | Institut für Versorgungsforschung | Koblenz | Germany | 56068 | |
| 56 | Universitatsmedizin Leipzig | Leipzig | Germany | 4103 | |
| 57 | Klinikum Großhadern der Ludwig-Maximilians-Universität | München | Germany | 81377 | |
| 58 | Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, | Tuebingen | Germany | 72076 | |
| 59 | Barzilai Medical Center | Ashkelon | Israel | 78741 | |
| 60 | Hillel Yaffe Medical Center | Hadera | Israel | 38100 | |
| 61 | Rambam Med.Center - Hematology Institute | Haifa | Israel | 3109601 | |
| 62 | Carmel Medical Center | Haifa | Israel | 3436212 | |
| 63 | Meir Hospital | Kfar Saba | Israel | 44281 | |
| 64 | Rabin Medical Center | Petah-Tiqva | Israel | 49100 | |
| 65 | Sheba Medical Center | Ramat Gan | Israel | 52621 | |
| 66 | Sourasky (Ichilov) Medical Center | Tel Aviv | Israel | 64239 | |
| 67 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 68 | Ogaki Municipal Hospital | Gifu | Japan | 503-8502 | |
| 69 | Kobe City Medical Center General Hospital | Hyogo | Japan | 650-0047 | |
| 70 | Kanazawa University Hospital | Kanazawa | Japan | 920-8641 | |
| 71 | National Hospital Organization Kumamoto Medical Center | Kumamoto-shi | Japan | 860-0008 | |
| 72 | University Hospital Kyoto Perfectural University of Medicine | Kyoto | Japan | 602-8566 | |
| 73 | National Hospital Organization Matsumoto Medical Center | Matsumoto | Japan | 399-8701 | |
| 74 | Matsuyama Red Cross Hospital | Matsuyama | Japan | 790-8524 | |
| 75 | Nagoya City University Hospital | Nagoya | Japan | 467-8602 | |
| 76 | National Hospital Organization Okayama Medical Center | Okayama | Japan | 701-1192 | |
| 77 | Japanese Red Cross Osaka Hospital | Osaka | Japan | 543-8555 | |
| 78 | National Hospital Organization Shibukawa Medical Center | Shibukawa | Japan | 377-0280 | |
| 79 | Japanese Red Cross Medical Center | Shibuya | Japan | 150-8935 | |
| 80 | VU Medisch Centrum | Amsterdam | Netherlands | 1081 HV | |
| 81 | Albert Schweitzer ziekenhuis-lokatie Dordwijk | Dordrecht | Netherlands | 3318 AT | |
| 82 | Erasmus MC | Rotterdam | Netherlands | 3015CE | |
| 83 | Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza | Brzozow | Poland | 36-200 | |
| 84 | Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | Poland | 41-500 | |
| 85 | Uniwersyteckie Centrum Medyczne | Gdansk | Poland | 80-214 | |
| 86 | Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Kielce | Poland | 25-734 | |
| 87 | Szpital Uniwersytecki w Krakowie | Krakow | Poland | 30-501 | |
| 88 | Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli | Lublin | Poland | 20090 | |
| 89 | Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po | Poznan | Poland | 60-569 | |
| 90 | Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka | Slupsk | Poland | 76-200 | |
| 91 | Instytut Hematologii i Transfuzjologii | Warszawa | Poland | 02-776 | |
| 92 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warszawa | Poland | 02-781 | |
| 93 | Hosp. Univ. Fundacion Alcorcon | Alcorcon | Spain | 28922 | |
| 94 | Hosp. Del Mar | Barcelona | Spain | 08003 | |
| 95 | Hosp. Univ. de Guadalajara | Guadalajara | Spain | 19002 | |
| 96 | Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | Spain | 28222 | |
| 97 | Hosp. Quiron Madrid Pozuelo | Pozuelo De Alarcon, Madrid | Spain | 28223 | |
| 98 | Hosp. Mutua Terrassa | Terrassa | Spain | 08221 | |
| 99 | Gulhane Egitim ve Arastirma Hastanesi | Ankara | Turkey | 06010 | |
| 100 | Hacettepe University Medical Faculty | Ankara | Turkey | 06100 | |
| 101 | Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital | Ankara | Turkey | 06200 | |
| 102 | Ankara University School of Medicine, Cebeci Hospital | Ankara | Turkey | 06590 | |
| 103 | Istanbul University Istanbul Medical Faculty | Istanbul | Turkey | 34093 | |
| 104 | Dokuz Eylul University Medical Faculty | Izmir | Turkey | 35340 | |
| 105 | Ondokuz Mayis Universitesi Tip Fakultesi | Samsun | Turkey | 55280 | |
| 106 | Monklands District General Hospital | Airdrie | United Kingdom | ML6 0JS | |
| 107 | Blackpool Victoria Hospital | Blackpool | United Kingdom | FY3 8NR | |
| 108 | University Hospital Wales | Cardiff | United Kingdom | CF14 4XN | |
| 109 | Colchester Hospital University NHS | Colchester | United Kingdom | CO4 5JL | |
| 110 | Leicester Royal Infirmary - Haematology | Leicester | United Kingdom | LE1 5WW | |
| 111 | Altnagelvin Hospital | Londonderry | United Kingdom | BT47 6SB | |
| 112 | North Manchester General Hospital | Manchester | United Kingdom | M8 6RL | |
| 113 | Derriford Hospital | Plymouth | United Kingdom | PL6 8DH | |
| 114 | New Cross Hospital | Wolverhampton | United Kingdom | WV10 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.- CR108529
- 2018-001545-13
- 54767414MMY3019