Multiple Myeloma Clinical Trial

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

Summary

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

View Eligibility Criteria

Eligibility Criteria

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 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

1590

Study ID:

NCT05552222

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 53 Locations for this study

See Locations Near You

Royal Prince Alfred Hospital
Camperdown , 2050, Australia
Barwon Health - University Hospital Geelong
Geelong , 3220, Australia
Calvary Mater Newcastle Hospital
New South Wales , 2298, Australia
Wollongong Hospital
Wollongong , 2500, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Institut Jules Bordet
Anderlecht , 1070, Belgium
Jolimont
Haine-Saint-Paul, La Louviere , 7100, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Universitair Ziekenhuis Leuven
Leuven , 3000, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk , 2610, Belgium
Fakultni nemocnice Brno
Brno - Bohunice , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Plzen
Plzen , 304 6, Czechia
APHP - Hopital Henri Mondor
Creteil , 94010, France
Hopital Claude Huriez
Lille , 59000, France
CHU Nantes
Nantes , 44093, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac cedex , 33604, France
CHU Lyon Sud
Pierre-Benite , 69310, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse , 31000, France
Klinikum Nuernberg Nord
Nuernberg , 90419, Germany
A O U Sant Orsola Malpighi
Bologna , 40138, Italy
Ospedale San Raffaele
Milan , 20132, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia , 27100, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Pusan National University Hospital
Busan , 49241, Korea, Republic of
National Cancer Center
Goyang si , 10408, Korea, Republic of
VUMC Amsterdam
Amsterdam , 1081 , Netherlands
Gelre Ziekenhuis
Apeldoorn , 7334 , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein , 3435 , Netherlands
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
Hosp. Univ. Virgen de Las Nieves
Granada , 18014, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Univ. Son Espases
Palma de Mallorca , 07120, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Mutua Terrassa
Terrassa , 08221, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Falu Lasarett
Falun , 791 8, Sweden
Skanes universitetssjukhus
Lund , 221 8, Sweden
Karolinska University Hospital, Huddinge
Stockholm , 141 8, Sweden
Universitetssjukhuset Orebro
Örebro , 701 8, Sweden
INSELSPITAL, Universitätsspital Bern
Bern , 3010, Switzerland
Kantonsspital St.Gallen
St. Gallen , 9007, Switzerland
Ankara University Medical Faculty
Ankara , 06590, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35340, Turkey
Ondokuz Mayis University
Samsun , 55280, Turkey
Blackpool Victoria Hospital
Blackpool , FY3 8, United Kingdom
Kent and Canterbury Hospital
Canterbury , CT1 3, United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
Imperial College Healthcare
London , W2 1N, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

1590

Study ID:

NCT05552222

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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