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).
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
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There are 53 Locations for this study
Camperdown , 2050, Australia
Geelong , 3220, Australia
New South Wales , 2298, Australia
Wollongong , 2500, Australia
Woolloongabba , 4102, Australia
Anderlecht , 1070, Belgium
Haine-Saint-Paul, La Louviere , 7100, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Brno - Bohunice , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Plzen , 304 6, Czechia
Creteil , 94010, France
Lille , 59000, France
Nantes , 44093, France
Pessac cedex , 33604, France
Pierre-Benite , 69310, France
Toulouse , 31000, France
Nuernberg , 90419, Germany
Bologna , 40138, Italy
Milan , 20132, Italy
Pavia , 27100, Italy
Rozzano , 20089, Italy
Torino , 10126, Italy
Busan , 49241, Korea, Republic of
Goyang si , 10408, Korea, Republic of
Amsterdam , 1081 , Netherlands
Apeldoorn , 7334 , Netherlands
Nieuwegein , 3435 , Netherlands
Katowice , 40-51, Poland
Kielce , 25-73, Poland
Granada , 18014, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Palma de Mallorca , 07120, Spain
Salamanca , 37007, Spain
Terrassa , 08221, Spain
Valencia , 46010, Spain
Falun , 791 8, Sweden
Lund , 221 8, Sweden
Stockholm , 141 8, Sweden
Örebro , 701 8, Sweden
Bern , 3010, Switzerland
St. Gallen , 9007, Switzerland
Ankara , 06590, Turkey
Izmir , 35340, Turkey
Samsun , 55280, Turkey
Blackpool , FY3 8, United Kingdom
Canterbury , CT1 3, United Kingdom
Edinburgh , EH4 2, United Kingdom
London , W2 1N, United Kingdom
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