Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma: A Phase 2 (IFM 2022-01)
概览
- 阶段
- 2 期
- 干预措施
- Teclistamab
- 疾病 / 适应症
- Multiple Myeloma
- 发起方
- Nantes University Hospital
- 入组人数
- 103
- 试验地点
- 19
- 主要终点
- Rate of sustained MRD negativity (NGS, 10^-5)
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD [-] [standard-risk] vs MRD [+] [high-risk] respectively).
The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.
研究者
入排标准
入选标准
- •Each potential patient must satisfy all of the following criteria to be enrolled in the study:
- •Age, Type of Patient, Disease Characteristics
- •Male or female patients must be at least 18 years of age at the time of consent younger than 66 years.
- •Documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone lesions (CRAB) criteria and measurable disease (Source: Rajkumar 2014)
- •Newly diagnosed patients eligible for high dose therapy and autologous Stem cell therapy.
- •Have a Karnofsky performance status score ≥50% (Eastern Cooperative Oncology Group ECOG performance status ECOG score ≤
- •Have clinical laboratory values meeting the following criteria.
- •Sex and Contraceptive/Barrier Requirements
- •A female patient of childbearing potential must have a negative serum pregnancy test within 10 to 14 days prior to the start of study treatment and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study and for a period of 6 months after the last dose of study treatments.
- •A female patient must be :
排除标准
- 未提供
研究组 & 干预措施
Teclistamab and Lenalidomide
Patients treated with Teclistamab and Lenalidomide for finite duration.
干预措施: Teclistamab
Teclistamab and Lenalidomide
Patients treated with Teclistamab and Lenalidomide for finite duration.
干预措施: Lenalidomide
Teclistamab and Lenalidomide
Patients treated with Teclistamab and Lenalidomide for finite duration.
干预措施: Bortezomib
Teclistamab and Lenalidomide
Patients treated with Teclistamab and Lenalidomide for finite duration.
干预措施: Daratumumab
Teclistamab and Lenalidomide
Patients treated with Teclistamab and Lenalidomide for finite duration.
干预措施: Dexamethasone
Talquetamab andTeclistamab
Patients treated with Teclistamab and Talquetamab for finite duration
干预措施: Teclistamab
Talquetamab andTeclistamab
Patients treated with Teclistamab and Talquetamab for finite duration
干预措施: Talquetamab
Talquetamab andTeclistamab
Patients treated with Teclistamab and Talquetamab for finite duration
干预措施: Lenalidomide
Talquetamab andTeclistamab
Patients treated with Teclistamab and Talquetamab for finite duration
干预措施: Bortezomib
Talquetamab andTeclistamab
Patients treated with Teclistamab and Talquetamab for finite duration
干预措施: Daratumumab
Talquetamab andTeclistamab
Patients treated with Teclistamab and Talquetamab for finite duration
干预措施: Dexamethasone
结局指标
主要结局
Rate of sustained MRD negativity (NGS, 10^-5)
时间窗: 38 months
Rate of conversion from positive MRD to negative MRD (NGS, 10^-5)
时间窗: 38 months
次要结局
- Number of the death(74 months)
- Number of responses(50 months)
- Number of progression-free survival(74 months)
- Rate of conversion from positive MRD to negative MRD (NGS, 10^-5).(23 months)
- Percenatge of time to response(74 months)
- Number of adverse events(50 months)
- Rate of sustained MRD negativity (NGS, 10^-6)(38 months)
- Rate of conversion from positive MRD to negative MRD (NGS, 10^-6).(38 months)
- Percentage of duration of response(74 months)