Janssen Research & Development, LLC
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).
Multiple Myeloma
Teclistamab
Daratumumab
Lenalidomide
Dexamethasone
Talquetamab
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 1590 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | October 25, 2022 |
Estimated Primary Completion Date : | April 30, 2031 |
Estimated Study Completion Date : | August 29, 2033 |
Arm | Intervention/treatment |
---|---|
Experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR) Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide. |
Drug: Teclistamab Drug: Daratumumab Drug: Lenalidomide |
Experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR) Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide. |
Drug: Daratumumab Drug: Lenalidomide Drug: Talquetamab |
Active Comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone. |
Drug: Daratumumab Drug: Lenalidomide Drug: Dexamethasone |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Royal Prince Alfred Hospital
Camperdown, Australia, 2050
Recruiting
Barwon Health - University Hospital Geelong
Geelong, Australia, 3220
Recruiting
Calvary Mater Newcastle Hospital
New South Wales, Australia, 2298
Recruiting
Wollongong Hospital
Wollongong, Australia, 2500
Recruiting
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Recruiting
Institut Jules Bordet
Anderlecht, Belgium, 1070
Recruiting
Jolimont
Haine-Saint-Paul, La Louviere, Belgium, 7100
Recruiting
Az Groeninge
Kortrijk, Belgium, 8500
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Recruiting
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, Belgium, 2610
Recruiting
Fakultni nemocnice Brno
Brno - Bohunice, Czechia, 625 00
Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia, 500 05
Recruiting
Fakultni nemocnice Plzen
Plzen, Czechia, 304 60
Recruiting
APHP - Hopital Henri Mondor
Creteil, France, 94010
Recruiting
Hopital Claude Huriez
Lille, France, 59000
Recruiting
CHU Nantes
Nantes, France, 44093
Recruiting
CHU de Bordeaux - Hospital Haut-Leveque
Pessac cedex, France, 33604
Recruiting
CHU Lyon Sud
Pierre-Benite, France, 69310
Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31000
Recruiting
Klinikum Nuernberg Nord
Nuernberg, Germany, 90419
Recruiting
A O U Sant Orsola Malpighi
Bologna, Italy, 40138
Recruiting
Ospedale San Raffaele
Milan, Italy, 20132
Recruiting
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, Italy, 27100
Recruiting
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Recruiting
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Recruiting
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Recruiting
National Cancer Center
Goyang si, Korea, Republic of, 10408
Recruiting
VUMC Amsterdam
Amsterdam, Netherlands, 1081 HV
Recruiting
Gelre Ziekenhuis
Apeldoorn, Netherlands, 7334 DZ
Recruiting
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Netherlands, 3435 CM
Recruiting
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Recruiting
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland, 25-734
Recruiting
Hosp. Univ. Virgen de Las Nieves
Granada, Spain, 18014
Recruiting
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Recruiting
Hosp. Univ. La Paz
Madrid, Spain, 28046
Recruiting
Hosp. Univ. Hm Sanchinarro
Madrid, Spain, 28050
Recruiting
Hosp. Univ. Son Espases
Palma de Mallorca, Spain, 07120
Recruiting
Hosp. Clinico Univ. de Salamanca
Salamanca, Spain, 37007
Recruiting
Hosp. Mutua Terrassa
Terrassa, Spain, 08221
Recruiting
Hosp. Clinico Univ. de Valencia
Valencia, Spain, 46010
Recruiting
Falu Lasarett
Falun, Sweden, 791 82
Recruiting
Skanes universitetssjukhus
Lund, Sweden, 221 85
Recruiting
Karolinska University Hospital, Huddinge
Stockholm, Sweden, 141 86
Recruiting
Universitetssjukhuset Orebro
Örebro, Sweden, 701 85
Recruiting
INSELSPITAL, Universitätsspital Bern
Bern, Switzerland, 3010
Recruiting
Kantonsspital St.Gallen
St. Gallen, Switzerland, 9007
Recruiting
Ankara University Medical Faculty
Ankara, Turkey, 06590
Completed
Dokuz Eylul University Medical Faculty
Izmir, Turkey, 35340
Recruiting
Ondokuz Mayis University
Samsun, Turkey, 55280
Recruiting
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
Recruiting
Kent and Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
Recruiting
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Recruiting
Imperial College Healthcare
London, United Kingdom, W2 1NY