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

• ClinicalTrials.gov Identifier: NCT03652064
• Recruitment Status: Active, not recruiting
• First Posted: August 29, 2018
• Last Update Posted: May 6, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

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
Multiple Myeloma	Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone	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

• Study Type: Interventional (Clinical Trial)
• 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: November 6, 2018
• Estimated Primary Completion Date: September 8, 2023
• Estimated Study Completion Date: April 30, 2025

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 Name: 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 Name: 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 Name: 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 Name: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• 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

United States, California

Innovative Clinical Research, Inc.

Whittier, California, United States, 90805

United States, Florida

Baptist MD Anderson

Jacksonville, Florida, United States, 32207

United States, Indiana

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States, 46804

United States, Kentucky

Norton Healthcare

Louisville, Kentucky, United States, 40207

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Boston University Medical Center

Boston, Massachusetts, United States, 02118

United States, Michigan

Cancer & Hematology Centers of Western Michigan, PC

Grand Rapids, Michigan, United States, 49503

United States, Missouri

Saint Luke's Hospital - Saint Luke's Cancer Specialists

Kansas City, Missouri, United States, 64111

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

United States, New Mexico

San Juan Oncology Associates

Farmington, New Mexico, United States, 87401

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

NYU Winthrop

Mineola, New York, United States, 11501

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Oregon

Good Samaritan Hospital Corvallis

Corvallis, Oregon, United States, 97330

United States, Pennsylvania

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232-1301

United States, South Carolina

Gibbs Cancer Center

Spartanburg, South Carolina, United States, 29303

United States, Texas

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Brazil

Universidade Estadual De Campinas

Campinas, Brazil, 13083-878

Liga Norte Riograndense Contra O Cancer

Natal, Brazil, 59062-000

União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS

Porto Alegre, Brazil, 90610-000

Ministerio da Saude - Instituto Nacional do Cancer

Rio de Janeiro, Brazil, 20230-130

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, Brazil, 22775-001

Instituto de Ensino e Pesquisa São Lucas

Sao Paulo, Brazil, 01236-030

Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

Sao Paulo, Brazil, 03102-002

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, Brazil, 01323-900

Clinica Sao Germano

São Paulo, Brazil, 01455-010

Hospital Santa Cruz

São Paulo, Brazil, 04122-000

Canada, Alberta

Tom Baker Cancer Centre

Calgary, Alberta, Canada, T2N 4N2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, British Columbia

The Gordon & Leslie Diamond Health Care Center

Vancouver, British Columbia, Canada, V5Z 1M9

Canada, Nova Scotia

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

Brampton Civic Hospital

Brampton, Ontario, Canada, L6R 3J7

Victoria Hospital

London, Ontario, Canada, N6A 5W9

Lakeridge Health Oshawa

Oshawa, Ontario, Canada, L1G-2B9

Canada, Quebec

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Canada

CHU de Québec -L'Hôtel-Dieu de Québec

Quebec, Canada, G1J 1Z4

Czechia

Fakultni nemocnice Brno

Brno, Czechia, 625 00

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Ostrava

Ostrava, Czechia, 708 52

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

Plzen, Czechia, 323 00

Vseobecna fakultni nemocnice v Praze

Praha 2, Czechia, 128 08

France

CHU Henri Mondor

Creteil N/a, France, 94010

Centre Hospitalier Départmental La Roche sur Yon

La Roche sur Yon Cedex 9, France, 85925

Hopital Claude Huriez

Lille, France, 59037

Institut Paoli Calmettes

Marseille Cedex 9, France, 13009

CHU de Montpellier, Hopital Saint-Eloi

Montpellier, France, 34295

CHU de Bordeaux - Hospital Haut-Leveque

Pessac cedex, France, 33604

Strasbourg Oncologie Libérale

Strasbourg, France, 67000

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse cedex 9, France, 31059

Germany

phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg

Aschaffenburg, Germany, 63739

Universitatsklinikum Freiburg

Freiburg, Germany, 79106

St. Josef-Krankenhaus Hamm-Bockum-Hövel

Hamm, Germany, 59075

Institut für Versorgungsforschung

Koblenz, Germany, 56068

Universitatsmedizin Leipzig

Leipzig, Germany, 4103

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany, 81377

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tuebingen, Germany, 72076

Israel

Barzilai Medical Center

Ashkelon, Israel, 78741

Hillel Yaffe Medical Center

Hadera, Israel, 38100

Rambam Med.Center - Hematology Institute

Haifa, Israel, 3109601

Carmel Medical Center

Haifa, Israel, 3436212

Meir Hospital

Kfar Saba, Israel, 44281

Rabin Medical Center

Petah-Tiqva, Israel, 49100

Sheba Medical Center

Ramat Gan, Israel, 52621

Sourasky (Ichilov) Medical Center

Tel Aviv, Israel, 64239

Japan

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Ogaki Municipal Hospital

Gifu, Japan, 503-8502

Kobe City Medical Center General Hospital

Hyogo, Japan, 650-0047

Kanazawa University Hospital

Kanazawa, Japan, 920-8641

National Hospital Organization Kumamoto Medical Center

Kumamoto-shi, Japan, 860-0008

University Hospital Kyoto Perfectural University of Medicine

Kyoto, Japan, 602-8566

National Hospital Organization Matsumoto Medical Center

Matsumoto, Japan, 399-8701

Matsuyama Red Cross Hospital

Matsuyama, Japan, 790-8524

Nagoya City University Hospital

Nagoya, Japan, 467-8602

National Hospital Organization Okayama Medical Center

Okayama, Japan, 701-1192

Japanese Red Cross Osaka Hospital

Osaka, Japan, 543-8555

National Hospital Organization Shibukawa Medical Center

Shibukawa, Japan, 377-0280

Japanese Red Cross Medical Center

Shibuya, Japan, 150-8935

Netherlands

VU Medisch Centrum

Amsterdam, Netherlands, 1081 HV

Albert Schweitzer ziekenhuis-lokatie Dordwijk

Dordrecht, Netherlands, 3318 AT

Erasmus MC

Rotterdam, Netherlands, 3015CE

Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

Brzozow, Poland, 36-200

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, Poland, 41-500

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-214

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, Poland, 25-734

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 30-501

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, Poland, 20090

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland, 60-569

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Slupsk, Poland, 76-200

Instytut Hematologii i Transfuzjologii

Warszawa, Poland, 02-776

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warszawa, Poland, 02-781

Spain

Hosp. Univ. Fundacion Alcorcon

Alcorcon, Spain, 28922

Hosp. Del Mar

Barcelona, Spain, 08003

Hosp. Univ. de Guadalajara

Guadalajara, Spain, 19002

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, Spain, 28222

Hosp. Quiron Madrid Pozuelo

Pozuelo De Alarcon, Madrid, Spain, 28223

Hosp. Mutua Terrassa

Terrassa, Spain, 08221

Turkey

Gulhane Egitim ve Arastirma Hastanesi

Ankara, Turkey, 06010

Hacettepe University Medical Faculty

Ankara, Turkey, 06100

Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey, 06200

Ankara University School of Medicine, Cebeci Hospital

Ankara, Turkey, 06590

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey, 34093

Dokuz Eylul University Medical Faculty

Izmir, Turkey, 35340

Ondokuz Mayis Universitesi Tip Fakultesi

Samsun, Turkey, 55280

United Kingdom

Monklands District General Hospital

Airdrie, United Kingdom, ML6 0JS

Blackpool Victoria Hospital

Blackpool, United Kingdom, FY3 8NR

University Hospital Wales

Cardiff, United Kingdom, CF14 4XN

Colchester Hospital University NHS

Colchester, United Kingdom, CO4 5JL

Leicester Royal Infirmary - Haematology

Leicester, United Kingdom, LE1 5WW

Altnagelvin Hospital

Londonderry, United Kingdom, BT47 6SB

North Manchester General Hospital

Manchester, United Kingdom, M8 6RL

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

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

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03652064
• Other Study ID Numbers: CR108529; 2018-001545-13 ( EudraCT Number ); 54767414MMY3019 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: August 29, 2018
• Last Update Posted: May 6, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Lenalidomide; Bortezomib; Daratumumab; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunologic Factors