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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04923893
Registration number
NCT04923893
Ethics application status
Date submitted
10/06/2021
Date registered
11/06/2021
Titles & IDs
Public title
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
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Scientific title
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
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Secondary ID [1]
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2021-001242-35
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Secondary ID [2]
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CR109015
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Universal Trial Number (UTN)
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Trial acronym
CARTITUDE-5
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Cilta-cel
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Experimental: Arm A: VRd+Rd (Standard Therapy) - Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.
Experimental: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel) - Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m\^2 intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily for 3 days) and Cilta-cel infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).
Treatment: Drugs: Bortezomib
Bortezomib will be administered SC.
Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally.
Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally.
Treatment: Drugs: Cilta-cel
Cilta-cel infusion will be administered.
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered intravenously.
Treatment: Drugs: Fludarabine
Fludarabine will be administered intravenously.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to 4 years and 5 months
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Secondary outcome [1]
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Sustained Minimal Residual Disease (MRD) Negative CR
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Assessment method [1]
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Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10\^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status.
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Timepoint [1]
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Up to 12 years and 5 months
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Secondary outcome [2]
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MRD Negative CR at 9 Months
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Assessment method [2]
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MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date.
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Timepoint [2]
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9 months
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Secondary outcome [3]
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Overall MRD Negative CR
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Assessment method [3]
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Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy.
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Timepoint [3]
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Up to 12 years and 5 months
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Overall survival is measured from the date of randomization to the date of the participant's death.
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Timepoint [4]
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Up to 12 years and 5 months
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Secondary outcome [5]
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Complete Response or Better
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Assessment method [5]
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CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.
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Timepoint [5]
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Up to 12 years and 5 months
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Secondary outcome [6]
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Time to Subsequent Anti-myeloma Therapy
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Assessment method [6]
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Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.
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Timepoint [6]
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Up to 12 years and 5 months
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Secondary outcome [7]
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Progression Free Survival on Next-line Therapy (PFS2)
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Assessment method [7]
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PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.
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Timepoint [7]
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Up to 12 years and 5 months
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Secondary outcome [8]
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Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs
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Assessment method [8]
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Number of participants with AEs, abnormalities in laboratory parameters (complete blood count \[CBC\] with differential, coagulation, chimeric antigen receptor T cell \[CAR-T\] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported.
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Timepoint [8]
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Up to 12 years and 5 months
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Secondary outcome [9]
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Arm B: Systemic Cytokine Concentrations
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Assessment method [9]
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Serum or plasma proteomic profiling of cytokines (such as interleukin \[IL\] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.
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Timepoint [9]
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Up to Day 112
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Secondary outcome [10]
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Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers
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Assessment method [10]
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CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response.
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Timepoint [10]
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Up to 12 years and 5 months
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Secondary outcome [11]
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Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)
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Assessment method [11]
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Levels of soluble BCMA will be reported.
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Timepoint [11]
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Up to 1 year
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Secondary outcome [12]
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Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence
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Assessment method [12]
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Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
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Timepoint [12]
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Up to 12 years and 5 months
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Secondary outcome [13]
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Arm B: Number of Participants with Anti-cilta-cel Antibodies
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Assessment method [13]
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Number of participants with anti-cilta-cel antibodies will be reported.
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Timepoint [13]
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Up to 12 years and 5 months
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Secondary outcome [14]
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Arm B: Number of Participants with Presence of Replication Competent Lentivirus
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Assessment method [14]
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Number of participants with presence of replication competent lentivirus will be reported.
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Timepoint [14]
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Up to 12 years and 5 months
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Secondary outcome [15]
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Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
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Assessment method [15]
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The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
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Timepoint [15]
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Baseline up to 12 years and 5 months
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Secondary outcome [16]
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Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
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Assessment method [16]
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The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
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Timepoint [16]
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Baseline up to 12 years and 5 months
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Secondary outcome [17]
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Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
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Assessment method [17]
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The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [17]
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Baseline up to 12 years and 5 months
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Secondary outcome [18]
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Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
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Assessment method [18]
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The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
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Timepoint [18]
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Baseline up to 12 years and 5 months
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Secondary outcome [19]
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Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items
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Assessment method [19]
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The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
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Timepoint [19]
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Up to 161 days
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Secondary outcome [20]
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Time to Worsening of Symptoms, Functioning and Overall Well-being
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Assessment method [20]
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Time to worsening is measured as the interval from the date of randomization to the start date of worsening in MySIm-Q symptom, impact, or total scores.
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Timepoint [20]
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Up to 12 year and 5 months
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Eligibility
Key inclusion criteria
* Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
* Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
* Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
* Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
* A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
* Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Frailty index of >=2 according to Myeloma Geriatric Assessment score
* Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
* Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
* Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
* Seropositive for human immunodeficiency virus (HIV)
* Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
* Participant must not require continuous supplemental oxygen
* Hepatitis B infection
* Hepatitis C infection
* Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
* Any therapy that is targeted to B-cell maturation antigen (BCMA)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/12/2034
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Actual
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Sample size
Target
650
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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Austin Health - Heidelberg
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Royal Brisbane and Womens Hospital - Herston
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Recruitment hospital [5]
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Alfred Health - Melbourne
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Recruitment hospital [6]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [7]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [8]
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Calvary Mater Newcastle Hospital - Waratah
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Recruitment hospital [9]
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Western Sydney Local Health District - Westmead
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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8006 - Melbourne
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment postcode(s) [8]
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2298 - Waratah
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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California
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Connecticut
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Florida
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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New York
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North Carolina
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Pennsylvania
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Austria
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Graz
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Vienna
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Antwerp
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Gent
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Leuven
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Belgium
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Liege
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Ostrava - Poruba
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Czechia
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Praha 2
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Denmark
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Aarhus C
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Denmark
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Copenhagen
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Odense C
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Finland
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Helsinki
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Finland
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Oulu
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Finland
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Turku
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France
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Lille Cedex
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France
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Nantes
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France
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Paris cedex 10
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France
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Poitiers
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France
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Toulouse cedex 9
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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München
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Germany
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Regensburg
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Germany
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Tubingen
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Germany
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Wuerzburg
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Dublin
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Japan
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Bunkyo Ku
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Japan
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Fukuoka
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Japan
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Hyôgo
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Japan
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Kanazawa
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Japan
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Kyoto
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Japan
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Nagoya
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Japan
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Okayama
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Japan
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Sapporo
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Japan
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Sendai
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Japan
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Shibuya
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Korea, Republic of
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Jeollanam-do
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Norway
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Oslo
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Poland
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Gdansk
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Gliwice
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Lublin
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Poland
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Poznan
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Warszawa
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Porto
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Murcia
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Pamplona
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Salamanca
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Linköping
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Sweden
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Lund
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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St. Gallen
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Leeds,
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
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Trial website
https://clinicaltrials.gov/study/NCT04923893
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for public queries
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Study Contact
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Address
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Phone
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844-434-4210
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04923893