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 - Study to Compare Tec-DR & Tal-DR with DRd in TI NDMM / MajesTEC-7

Janssen-Cilag0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•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
•- 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 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
•For a full list of exclusion criteria, please refer to section 5.2 of the study

发起方