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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05552222




Registration number
NCT05552222
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022
Date last updated
24/10/2024

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
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
Secondary ID [1] 0 0
64007957MMY3005
Secondary ID [2] 0 0
CR109237
Universal Trial Number (UTN)
Trial acronym
MajesTEC-7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional(has expanded access)
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From randomization to the date of disease progression or death (Up to 09 years)
Primary outcome [2] 0 0
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
Timepoint [2] 0 0
At Month 12
Secondary outcome [1] 0 0
Very Good Partial Response (VGPR) or Better
Timepoint [1] 0 0
From randomization up to 09 years
Secondary outcome [2] 0 0
Complete Response (CR) or Better
Timepoint [2] 0 0
From randomization up to 09 years
Secondary outcome [3] 0 0
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
Timepoint [3] 0 0
From randomization up to 09 years
Secondary outcome [4] 0 0
MRD-negative CR
Timepoint [4] 0 0
From randomization up to 09 years
Secondary outcome [5] 0 0
Progression Free Survival on Next-line Therapy (PFS2)
Timepoint [5] 0 0
From randomization up to 09 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
From randomization to the date of death (up to 09 years)
Secondary outcome [7] 0 0
Number of Participants with Adverse Events (AEs) by Severity
Timepoint [7] 0 0
From randomization up to 09 years
Secondary outcome [8] 0 0
Number of Participants with Abnormalities in Laboratory Parameters
Timepoint [8] 0 0
From randomization up to 09 years
Secondary outcome [9] 0 0
Number of Participants with Abnormalities in Vital Signs
Timepoint [9] 0 0
From randomization up to 09 years
Secondary outcome [10] 0 0
Number of Participants with Abnormalities in Physical Examination
Timepoint [10] 0 0
From randomization up to 09 years
Secondary outcome [11] 0 0
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Timepoint [11] 0 0
From randomization up to 09 years
Secondary outcome [12] 0 0
Serum Concentrations of Teclistamab and Talquetamab
Timepoint [12] 0 0
From randomization up to 09 years
Secondary outcome [13] 0 0
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
Timepoint [13] 0 0
From randomization up to 09 years
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
From baseline up to 9 years
Secondary outcome [15] 0 0
Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [15] 0 0
Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
Secondary outcome [16] 0 0
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Timepoint [16] 0 0
From baseline up to 9 years
Secondary outcome [17] 0 0
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
Timepoint [17] 0 0
From randomization up to 09 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2033
Actual
Sample size
Target
1590
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [5] 0 0
Calvary Mater Newcastle Hospital - New South Wales
Recruitment hospital [6] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2298 - New South Wales
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
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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Belgium
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Anderlecht
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Belgium
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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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Barretos
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Belo Horizonte
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Curitiba
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Fortaleza
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Natal
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Niteroi
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Salvador
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Alberta
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Beijing
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Chang Zhou
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China
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Changchun
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Chongqing
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Fu Zhou
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China
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Guangzhou
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China
State/province [31] 0 0
Hang Zhou
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China
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Hangzhou
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China
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Harbin
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China
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Jinan
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China
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Nan Jing
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China
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Nan Ning Shi
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China
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Nanchang
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China
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China
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Shen Zhen Shi
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China
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China
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Tian Jin
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Tianjin
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Wenzhou
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WuHan
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Xi' An
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Zhengzhou
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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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Ostrava
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Plzen
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Praha
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Aalborg
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Herning
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PARIS cedex 12
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Pessac cedex
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Pierre-Benite
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Toulouse
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Halle (Saale)
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Germany
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Hamburg
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Germany
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Nuernberg
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Germany
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Tübingen
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Wurzburg
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Athens Attica
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Pavia
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Roma
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Rozzano
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Italy
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Torino
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Bunkyo-Ku
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Chiba
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Higashiibaraki-gun
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Hirakata
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Hyôgo
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Iruma-gun
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Kanagawa
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Kanazawa
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Kumamoto-shi
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Matsuyama-City
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Nagasaki
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Okayama
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Osaka
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Sapporo
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Shibukawa
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Sunto-gun
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Japan
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Yamagata
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Japan
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Yamanashi
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang si
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Korea, Republic of
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Hwasun
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Korea, Republic of
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Incheon
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Seoul
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Amsterdam
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Apeldoorn
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Delft
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Nieuwegein
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Sittard-Geleen
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Norway
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Oslo
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Norway
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Trondheim
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Biala Podlaska
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Brzozow
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Bydgoszcz
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Katowice
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Kielce
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Lublin
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Zielona Gora
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Portugal
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Braga
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Portugal
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Lisbon
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Porto
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Badalona
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Spain
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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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Pozuelo de Alarcon
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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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Antalya
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Turkey
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Denizli
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Turkey
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Istanbul
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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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Bristol
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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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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT05552222
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05552222