ISRCTN72661732进行中（未招募）3 期
A phase III randomized study comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,030
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 03/01/2024:
- •1. Sex: All
- •2. Gender-Based: No
- •3. Aged 18 years old and over
- •4. Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •5. 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
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- •7. 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
- •8. 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
- •Previous inclusion criteria from 14/09/2023 to 03/01/2024:
- •1. Sex: All
- •2. Gender-Based: No
- •3. Aged 18 years old and over
- •4. Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •5. 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
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- •7. 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
- •8. A 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.
- •Previous inclusion criteria:
- •1. Sex: All
- •2. Gender-Based: No
- •3. Aged 18 years old and over
- •4. Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •5. Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to:
- •5.1. Advanced age OR
- •5.2. Presence of comorbid condition(s) likely to have a negative impact on the tolerability of high-dose chemotherapy with ASCT OR
- •5.3. Deferral of high-dose chemotherapy with ASCT as initial treatment
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- •7. A 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 treatment
- •8. A 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
排除标准
- •Current exclusion criteria as of 14/09/2023:
- •1. Received any prior therapy for multiple myeloma or smouldering 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
- •2. Had plasmapheresis within 28 days of randomisation
- •3. Had a stroke, transient ischaemic attack, or seizure within 6 months prior to randomisation
- •4. Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
- •5. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
- •6. Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone
- •Previous exclusion criteria:
- •1. Received a cumulative dose of systemic corticosteroids equivalent to greater than or equal to (>=) 20 milligrams (mg) of dexamethasone within 14 days before randomisation
- •2. Had plasmapheresis within 28 days of randomisation
- •3. Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomisation
- •4. Known allergies, hypersensitivity, or intolerance to teclistamab excipients
- •5. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
研究者
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