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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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daratumumab
Bortezomib
Lenalidomide
Dexamethasone
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Innovative Clinical Research, Inc.
  • Baptist MD Anderson
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • Norton Healthcare
  • Tufts Medical Center
  • Boston University Medical Center
  • Cancer & Hematology Centers of Western Michigan, PC
  • Saint Luke's Hospital - Saint Luke's Cancer Specialists
  • Rutgers Cancer Institute of New Jersey
  • San Juan Oncology Associates
  • Roswell Park Cancer Institute
  • NYU Winthrop
  • Levine Cancer Institute
  • Cleveland Clinic
  • Good Samaritan Hospital Corvallis
  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
  • Gibbs Cancer Center
  • University of Texas, MD Anderson Cancer Center
  • University of Virginia
  • Universidade Estadual De Campinas
  • Liga Norte Riograndense Contra O Cancer
  • União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
  • Ministerio da Saude - Instituto Nacional do Cancer
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Instituto de Ensino e Pesquisa São Lucas
  • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
  • Real e Benemérita Associação Portuguesa de Beneficência
  • Clinica Sao Germano
  • Hospital Santa Cruz
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • The Gordon & Leslie Diamond Health Care Center
  • QEII Health Sciences Centre
  • Brampton Civic Hospital
  • Victoria Hospital
  • Lakeridge Health Oshawa
  • McGill University Health Centre
  • CHU de Québec -L'Hôtel-Dieu de Québec
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
  • Vseobecna fakultni nemocnice v Praze
  • CHU Henri Mondor
  • Centre Hospitalier Départmental La Roche sur Yon
  • Hopital Claude Huriez
  • Institut Paoli Calmettes
  • CHU de Montpellier, Hopital Saint-Eloi
  • CHU de Bordeaux - Hospital Haut-Leveque
  • Strasbourg Oncologie Libérale
  • Institut Universitaire du cancer de Toulouse-Oncopole
  • phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg
  • Universitatsklinikum Freiburg
  • St. Josef-Krankenhaus Hamm-Bockum-Hövel
  • Institut für Versorgungsforschung
  • Universitatsmedizin Leipzig
  • Klinikum Großhadern der Ludwig-Maximilians-Universität
  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
  • Barzilai Medical Center
  • Hillel Yaffe Medical Center
  • Rambam Med.Center - Hematology Institute
  • Carmel Medical Center
  • Meir Hospital
  • Rabin Medical Center
  • Sheba Medical Center
  • Sourasky (Ichilov) Medical Center
  • Fukuoka University Hospital
  • Ogaki Municipal Hospital
  • Kobe City Medical Center General Hospital
  • Kanazawa University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • University Hospital Kyoto Perfectural University of Medicine
  • National Hospital Organization Matsumoto Medical Center
  • Matsuyama Red Cross Hospital
  • Nagoya City University Hospital
  • National Hospital Organization Okayama Medical Center
  • Japanese Red Cross Osaka Hospital
  • National Hospital Organization Shibukawa Medical Center
  • Japanese Red Cross Medical Center
  • VU Medisch Centrum
  • Albert Schweitzer ziekenhuis-lokatie Dordwijk
  • Erasmus MC
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • Uniwersyteckie Centrum Kliniczne
  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • NSSU Szpital Uniwersytecki w Krakowie
  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
  • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
  • Instytut Hematologii i Transfuzjologii
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Hosp. Univ. Fundacion Alcorcon
  • Hosp. Del Mar
  • Hosp. Univ. de Guadalajara
  • Hosp. Univ. Pta. de Hierro Majadahonda
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Mutua Terrassa
  • Gulhane Egitim ve Arastirma Hastanesi
  • Hacettepe University Medical Faculty
  • Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara University School of Medicine, Cebeci Hospital
  • Istanbul University Istanbul Medical Faculty
  • Dokuz Eylul University Medical Faculty
  • Ondokuz Mayis Universitesi Tip Fakultesi
  • Monklands District General Hospital
  • Blackpool Victoria Hospital
  • University Hospital Wales
  • Colchester Hospital University NHS
  • Leicester Royal Infirmary - Haematology
  • Altnagelvin Hospital
  • North Manchester General Hospital
  • Derriford Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bortezomib + Lenalidomide + Dexamethasone (VRd) and Rd

Daratumumab + VRd (D-VRd) and DRd

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Negative Minimal Residual Disease (MRD) Status
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)
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
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
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)
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
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
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
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)
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
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)
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
The Cmax is the maximum observed serum concentration of daratumumab.
Minimum Observed Serum Concentration (Cmin) of Daratumumab
The Cmin is the minimum observed serum concentration of daratumumab.
Number of Participants with Anit-daratumumab Antibodies
Number of participants with anti-daratumumab antibodies will be assessed.
Number of Participants with Anit-rHuPH20 Antibodies
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)
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)
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)
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.

Full Information

First Posted
August 17, 2018
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03652064
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
August 29, 2025 (Anticipated)
Study Completion Date
August 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bortezomib + Lenalidomide + Dexamethasone (VRd) and Rd
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Daratumumab + VRd (D-VRd) and DRd
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
JNJ-54767414, DARZALEX
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants with Negative Minimal Residual Disease (MRD) Status
Description
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.
Time Frame
After randomization and prior to progressive disease (PD) or the start of subsequent anti-myeloma therapy approximately 2.5 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
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)
Title
MRD Negative Rate
Description
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.
Time Frame
12,18 and 24 Months
Title
Durable MRD Negative Rate
Description
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.
Time Frame
Throughout the study (approximately 6 year)
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Up to the end of the study (approximately 6 years)
Title
Very Good Partial Response (VGPR) or Better Rate
Description
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.
Time Frame
Approximately 6 years
Title
Complete Response (CR) or Better Rate
Description
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.
Time Frame
Approximately 6 years
Title
PFS on the Next Line of Therapy
Description
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.
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)
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.
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)
Title
Time to Response
Description
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.
Time Frame
From randomization until PR or better until approximately 6 years
Title
Duration of Response (DOR)
Description
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.
Time Frame
From initial documentation of response to the date of PD until approximately 6 years
Title
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Description
The Cmax is the maximum observed serum concentration 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)
Title
Minimum Observed Serum Concentration (Cmin) of Daratumumab
Description
The Cmin is the minimum observed serum concentration 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)
Title
Number of Participants with Anit-daratumumab Antibodies
Description
Number of participants with anti-daratumumab antibodies will be assessed.
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)
Title
Number of Participants with Anit-rHuPH20 Antibodies
Description
Number of participants with anti-recombinant human hyaluronidase (rHuPH20) antibodies will be assessed.
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)
Title
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)
Description
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.
Time Frame
Baseline, up to 6 years (end of study)
Title
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)
Description
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).
Time Frame
Baseline, up to 6 years (end of study)
Title
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Description
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.
Time Frame
Baseline, up to 6 years (end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Innovative Clinical Research, Inc.
City
Whittier
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Baptist MD Anderson
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Saint Luke's Hospital - Saint Luke's Cancer Specialists
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
NYU Winthrop
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Good Samaritan Hospital Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232-1301
Country
United States
Facility Name
Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Universidade Estadual De Campinas
City
Campinas
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59062-000
Country
Brazil
Facility Name
União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Ministerio da Saude - Instituto Nacional do Cancer
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa São Lucas
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
City
Sao Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
ZIP/Postal Code
01323-900
Country
Brazil
Facility Name
Clinica Sao Germano
City
São Paulo
ZIP/Postal Code
01455-010
Country
Brazil
Facility Name
Hospital Santa Cruz
City
São Paulo
ZIP/Postal Code
04122-000
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
The Gordon & Leslie Diamond Health Care Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G-2B9
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU de Québec -L'Hôtel-Dieu de Québec
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
City
Plzen
ZIP/Postal Code
323 00
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU Henri Mondor
City
Creteil N/a
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Départmental La Roche sur Yon
City
La Roche sur Yon Cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Montpellier, Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Bordeaux - Hospital Haut-Leveque
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Strasbourg Oncologie Libérale
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Institut Universitaire du cancer de Toulouse-Oncopole
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
St. Josef-Krankenhaus Hamm-Bockum-Hövel
City
Hamm
ZIP/Postal Code
59075
Country
Germany
Facility Name
Institut für Versorgungsforschung
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Universitatsmedizin Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Klinikum Großhadern der Ludwig-Maximilians-Universität
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78741
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Med.Center - Hematology Institute
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Meir Hospital
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center
City
Petah-Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky (Ichilov) Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto-shi
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Matsumoto
ZIP/Postal Code
399-8701
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
National Hospital Organization Shibukawa Medical Center
City
Shibukawa
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Albert Schweitzer ziekenhuis-lokatie Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
NSSU Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
City
Lublin
ZIP/Postal Code
20090
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hosp. Univ. Fundacion Alcorcon
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hosp. Univ. de Guadalajara
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hosp. Univ. Pta. de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo De Alarcon, Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hosp. Mutua Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Gulhane Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Ankara University School of Medicine, Cebeci Hospital
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi
City
Samsun
ZIP/Postal Code
55280
Country
Turkey
Facility Name
Monklands District General Hospital
City
Airdrie
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
University Hospital Wales
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Colchester Hospital University NHS
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Leicester Royal Infirmary - Haematology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Altnagelvin Hospital
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 6RL
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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