Last updated 15 days ago
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
1590 patients around the world
Available in United States, Spain
Janssen Research & Development, LLC
8Research sites
1590Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteriaBe 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 treatmentHave an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatmentA male participant must agree not to plan to father a child while enrolled in this study or within 3 months after the last dose of study treatment
- Received a cumulative dose of systemic corticosteroids equivalent to greater than or equal to (>=) 20 milligrams (mg) of dexamethasone within 14 days before randomizationHad plasmapheresis within 28 days of randomizationHad a stroke, transient ischemic attack, or seizure within 6 months prior to randomizationKnown allergies, hypersensitivity, or intolerance to teclistamab excipientsKnown contraindications to the use of daratumumab or lenalidomide per local prescribing information
Sites
Hospital Universitario Virgen de las Nieves
Recruiting
Hospital Universitario 12 de Octubre
Recruiting
Hospital Universitario La Paz
Recruiting
Hospital HM Sanchinarro
Recruiting
Hospital Clínico Universitario de Salamanca
Recruiting
Hospital Universitari MútuaTerrassa
Recruiting
Hospital Clínico Universitario de Valencia
Recruiting
Hospital Universitari Son Espases
Recruiting
StudyMajesTEC-7
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05552222
