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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05552222
Registration number
NCT05552222
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022
Date last updated
24/04/2024
Titles & IDs
Public title
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
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Scientific title
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
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Secondary ID [1]
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64007957MMY3005
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Secondary ID [2]
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CR109237
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Universal Trial Number (UTN)
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Trial acronym
MajesTEC-7
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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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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 - Teclistamab
Treatment: Drugs - Daratumumab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Talquetamab
Experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR) - Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR) - Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Active Comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) - Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.
Treatment: Drugs: Teclistamab
Teclistamab will be administered as SC injection.
Treatment: Drugs: Daratumumab
Daratumumab will be administered as SC injection.
Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally.
Treatment: Drugs: Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
Treatment: Drugs: Talquetamab
Talquetamab will be administered as SC injection.
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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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PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria.
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Timepoint [1]
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From randomization to the date of disease progression or death (Up to 9 years)
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Primary outcome [2]
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Complete Response (CR) or Better
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Assessment method [2]
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CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.
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Timepoint [2]
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From randomization up to 9 years
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Secondary outcome [1]
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Very Good Partial Response (VGPR) or Better
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Assessment method [1]
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VGPR or better is defined as the percentage of participants achieving VGPR and CR (including sCR) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.
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Timepoint [1]
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From randomization up to 9 years
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Secondary outcome [2]
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Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
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Assessment method [2]
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Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by next-generation sequencing (NGS) with sensitivity of 10^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between.
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Timepoint [2]
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From randomization up to 9 years
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Secondary outcome [3]
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MRD-negative CR
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Assessment method [3]
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MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better.
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Timepoint [3]
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From randomization up to 9 years
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Secondary outcome [4]
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Progression Free Survival on Next-line Therapy (PFS2)
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Assessment method [4]
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PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease 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 [4]
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From randomization up to 9 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [5]
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From randomization to the date of death (up to 9 years)
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Secondary outcome [6]
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Number of Participants with Adverse Events (AEs) by Severity
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Assessment method [6]
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An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
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Timepoint [6]
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From randomization up to 9 years
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Secondary outcome [7]
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Number of Participants with Abnormalities in Laboratory Parameters
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Assessment method [7]
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Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
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Timepoint [7]
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From randomization up to 9 years
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Secondary outcome [8]
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Number of Participants with Abnormalities in Vital Signs
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Assessment method [8]
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Number of participants with abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
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Timepoint [8]
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From randomization up to 9 years
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Secondary outcome [9]
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Number of Participants with Abnormalities in Physical Examination
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Assessment method [9]
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Number of participants with abnormalities in physical examination will be reported.
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Timepoint [9]
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From randomization up to 9 years
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Secondary outcome [10]
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Number of Participants with Abnormalities in Electrocardiogram (ECG)
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Assessment method [10]
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Number of participants with abnormalities in ECG will be reported.
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Timepoint [10]
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From randomization up to 9 years
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Secondary outcome [11]
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Serum Concentrations of Teclistamab and Talquetamab
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Assessment method [11]
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Serum samples will be analyzed to determine concentrations of teclistamab and talquetamab using validated, specific, and sensitive methods.
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Timepoint [11]
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From randomization up to 9 years
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Secondary outcome [12]
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Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
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Assessment method [12]
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Number of participants with ADAs to teclistamab and talquetamab will be reported.
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Timepoint [12]
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From randomization up to 9 years
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Secondary outcome [13]
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Change from Baseline in Symptoms, Functioning, and 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)
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Assessment method [13]
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The EORTC-QLQ-C30 Version 3 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 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("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 high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [13]
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From baseline up to 9 years
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Secondary outcome [14]
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Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [14]
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The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
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Timepoint [14]
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Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
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Secondary outcome [15]
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Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
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Assessment method [15]
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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).
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Timepoint [15]
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From baseline up to 9 years
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Secondary outcome [16]
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Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
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Assessment method [16]
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Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change.
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Timepoint [16]
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From randomization up to 9 years
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Eligibility
Key inclusion criteria
- Have a diagnosis of multiple myeloma according to the International Myeloma Working
Group (IMWG) diagnostic criteria
- Be newly diagnosed and not considered a candidate for high-dose chemotherapy with
autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR;
ineligible due to the 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- A participant must agree not to be pregnant, breastfeeding, or planning to become
pregnant while enrolled in this study or within 6 months after the last dose of study
treatment
- A participant must agree not to plan to father a child while enrolled in this study or
within 100 days after the last dose of study treatment
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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
- Received any prior therapy for multiple myeloma or smoldering myeloma other than a
short course of corticosteroids (not to exceed 40 milligrams [mg] of dexamethasone, or
equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or
equivalent). In addition, received a cumulative dose of systemic corticosteroids
equivalent to greater than or equals to (>=)20 mg of dexamethasone during the
Screening Phase
- Had plasmapheresis within 28 days of randomization
- Had a stroke, transient ischemic attack, or seizure within 6 months prior to
randomization
- Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab
excipients
- Known contraindications to the use of daratumumab or lenalidomide per local
prescribing information
- Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2
based on age alone
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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
25/10/2022
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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
28/10/2033
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Actual
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Sample size
Target
1590
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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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Barwon Health - University Hospital Geelong - Geelong
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Recruitment hospital [3]
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Calvary Mater Newcastle Hospital - New South Wales
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Recruitment hospital [4]
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Wollongong Hospital - Wollongong
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Recruitment hospital [5]
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Princess Alexandra Hospital - Woolloongabba
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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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3220 - Geelong
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Recruitment postcode(s) [3]
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2298 - New South Wales
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment outside Australia
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Belgium
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Anderlecht
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Belgium
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Haine-Saint-Paul, La Louviere
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Wilrijk
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Czechia
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Brno - Bohunice
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Czechia
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Hradec Kralove
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Czechia
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Plzen
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France
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Creteil
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France
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Lille
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France
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Nantes
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France
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Pessac cedex
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France
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Pierre-Benite
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France
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Toulouse
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Germany
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Nuernberg
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Italy
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Bologna
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Italy
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Milan
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Italy
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Pavia
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Italy
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Rozzano
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Italy
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Torino
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Korea, Republic of
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Busan
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Korea, Republic of
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Goyang si
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Netherlands
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Amsterdam
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Netherlands
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Apeldoorn
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Netherlands
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Nieuwegein
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Poland
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Katowice
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Poland
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Kielce
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Spain
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Granada
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Salamanca
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Spain
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Terrassa
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Spain
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Valencia
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Sweden
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Falun
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Örebro
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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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Turkey
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Ankara
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Turkey
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Izmir
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Turkey
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Samsun
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United Kingdom
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Blackpool
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United Kingdom
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Canterbury
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United Kingdom
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Edinburgh
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United Kingdom
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London
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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 teclistamab in combination with
daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and
lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05552222
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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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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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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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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05552222
Download to PDF