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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record athttps://clinicaltrials.gov/study/NCT05552222
Registration number
NCT05552222
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022
Date last updated
19/06/2024
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]00
64007957MMY3005
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Secondary ID [2]00
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 Myeloma00
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Condition category
Condition code
Cancer0000
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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 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 Treatment: Drugs: Daratumumab Treatment: Drugs: Lenalidomide Treatment: Drugs: Dexamethasone Treatment: Drugs: Talquetamab
Treatment: Drugs - Daratumumab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Talquetamab
Teclistamab will be administered as SC injection.
Daratumumab will be administered as SC injection.
Lenalidomide will be administered orally.
Dexamethasone will be administered either orally or intravenously (IV).
Talquetamab will be administered as SC injection.
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Intervention code [1]00
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]00
Progression Free Survival (PFS)
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Timepoint [1]00
From randomization to the date of disease progression or death (Up to 09 years)
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Primary outcome [2]00
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
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Timepoint [2]00
At Month 12
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Secondary outcome [1]00
Very Good Partial Response (VGPR) or Better
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Timepoint [1]00
From randomization up to 09 years
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Secondary outcome [2]00
Complete Response (CR) or Better
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Timepoint [2]00
From randomization up to 09 years
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Secondary outcome [3]00
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
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Timepoint [3]00
From randomization up to 09 years
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Secondary outcome [4]00
MRD-negative CR
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Timepoint [4]00
From randomization up to 09 years
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Secondary outcome [5]00
Progression Free Survival on Next-line Therapy (PFS2)
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Timepoint [5]00
From randomization up to 09 years
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Secondary outcome [6]00
Overall Survival (OS)
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Timepoint [6]00
From randomization to the date of death (up to 09 years)
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Secondary outcome [7]00
Number of Participants with Adverse Events (AEs) by Severity
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Timepoint [7]00
From randomization up to 09 years
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Secondary outcome [8]00
Number of Participants with Abnormalities in Laboratory Parameters
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Timepoint [8]00
From randomization up to 09 years
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Secondary outcome [9]00
Number of Participants with Abnormalities in Vital Signs
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Timepoint [9]00
From randomization up to 09 years
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Secondary outcome [10]00
Number of Participants with Abnormalities in Physical Examination
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Timepoint [10]00
From randomization up to 09 years
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Secondary outcome [11]00
Number of Participants with Abnormalities in Electrocardiogram (ECG)
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Timepoint [11]00
From randomization up to 09 years
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Secondary outcome [12]00
Serum Concentrations of Teclistamab and Talquetamab
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Timepoint [12]00
From randomization up to 09 years
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Secondary outcome [13]00
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
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Timepoint [13]00
From randomization up to 09 years
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Secondary outcome [14]00
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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Timepoint [14]00
From baseline up to 9 years
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Secondary outcome [15]00
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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Timepoint [15]00
Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
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Secondary outcome [16]00
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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Timepoint [16]00
From baseline up to 9 years
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Secondary outcome [17]00
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
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Timepoint [17]00
From randomization up to 09 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
18Years
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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 total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization
* 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 concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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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]00
Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]00
Barwon Health - University Hospital Geelong - Geelong
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Recruitment hospital [3]00
Calvary Mater Newcastle Hospital - New South Wales
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Recruitment hospital [4]00
Wollongong Hospital - Wollongong
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Recruitment hospital [5]00
Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]00
2050 - Camperdown
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Recruitment postcode(s) [2]00
3220 - Geelong
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Recruitment postcode(s) [3]00
2298 - New South Wales
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Recruitment postcode(s) [4]00
2500 - Wollongong
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Recruitment postcode(s) [5]00
4102 - Woolloongabba
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Recruitment outside Australia
Country [1]00
Belgium
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State/province [1]00
Anderlecht
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Belgium
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State/province [2]00
Gent
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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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Brazil
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Natal
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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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Alberta
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China
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Fu Zhou
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China
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Guangzhou
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China
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Shanghai
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China
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Tian Jin
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China
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WuHan
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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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Olomouc
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Czechia
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Ostrava
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Czechia
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Plzen
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Czechia
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Praha
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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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France
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PARIS cedex 12
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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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Poitiers
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France
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Rennes
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France
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Toulouse
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Germany
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Berlin
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Germany
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Nuernberg
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Germany
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Tübingen
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Germany
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Würzburg
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Greece
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Athens Attica
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Greece
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Greece
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Israel
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Haifa
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Italy
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Italy
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Italy
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Pavia
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Torino
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Kanazawa
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Japan
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Yamagata
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Japan
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Yamanashi
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Busan
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Goyang si
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Hwasun
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Incheon
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Seoul
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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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Oslo
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Trondheim
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Katowice
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Kielce
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Braga
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Portugal
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Lisbon
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Portugal
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Porto
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Badalona
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Barcelona
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Spain
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Granada
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Spain
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Jerez de la Frontera
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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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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/study/NCT05552222
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name00
Janssen Research & Development, LLC Clinical Trial
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Address00
Janssen Research & Development, LLC
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Phone00
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Email00
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Contact person for public queries
Name00
Study Contact
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Address00
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Country00
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Phone00
844-434-4210
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Fax00
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Email00
[emailprotected]
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Contact person for scientific queries
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
For IPD and results data, please seehttps://clinicaltrials.gov/study/NCT05552222
