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
Phase 3 – large-scale trial before approval
Conditions:
Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
trial.available_in:
БГ
Overview
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).
Who can participate
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
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
Locations
21
Australia (1)
Royal Prince Alfred Hospital
Camperdown
Belgium (1)
Institut Jules Bordet
Anderlecht
Brazil (1)
Fundacao Pio XII
Barretos
Canada (1)
Arthur J E Child Comprehensive Cancer Centre
Calgary , Alberta
China (1)
Peking Union Medical College Hospital
Beijing
Czech Republic (1)
Fakultni nemocnice Brno
Brno-Bohunice
Denmark (1)
Aalborg University Hospital
Aalborg
France (1)
CHU Henri Mondor
Créteil
Greece (1)
Alexandra General Hospital of Athens
Athens Attica
Israel (1)
Soroka Medical Center
Beersheba
Italy (1)
ASST Papa Giovanni XXIII Bergamo
Bergamo
Japan (1)
Juntendo University Hospital
Bunkyō City
Netherlands (1)
VUMC Amsterdam
Amsterdam
Norway (1)
Oslo University Hospital HF Ulleval sykehus
Oslo
Poland (1)
Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
Biała Podlaska
COMPLETED
South Korea (1)
Dong-A University Hospital
Busan
Spain (1)
Hosp. Univ. Germans Trias I Pujol
Badalona
Sweden (1)
Falu Lasarett
Falun
Turkey (1)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
United Kingdom (1)
University Hospitals Birmingham NHS Foundation Trust