Efficacy of Response-adapted Treatment Guided by Negative Minimal Residual Disease and Negative Imaging (MRDI) in Fit Patients Diagnosed With Multiple Myeloma Who Are Candidates for Bone Marrow Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 主要终点
- Average grade 3 or higher adverse events per patient
研究概览
简要总结
To assess whether continued treatment to achieve negative Minimal Residual Disease and Imaging (MRDI(-)) improves therapeutic outcomes in patients with newly diagnosed Multiple Myeloma. The primary endpoints are progression-free survival (PFS) and overall survival (OS). The safety evaluation includes the evaluation of adverse events, which are classified according to the Common Criteria for Terminology for Adverse Events of the National Cancer Institute, version 5.0.
详细描述
Material and methods - Criteria for Enrollment Patients younger than 76 years, diagnosed with myeloma since July 1, 2014 until May 31, 2019, without a contraindication for bone marrow auto-transplantation are included in the study. Fragile patients with severe senile dementia, with another non-treatable neoplasm, or with significant comorbidity in whom the therapeutic objective was only palliative are not included in the study. The allocation to each treatment group was carried out according to the patient's preferences and his/her responsible physician, giving the patient his/her consent for treatment in all cases. In addition to other information, before patients gave their consent, patients included in the continued treatment group were clarified that it was a non-standard treatment, giving them the choice between the most common option of fixed treatment or continuous treatment up to Minimal Residual Disease and Image negative (MRDI(-)).
Material and methods - Study Design and Treatment This is a study of the patients treated in real life hematology. It is a cohort study to compare continuous treatment versus fixed-duration therapy. The study is conducted in a single hospital, including patients diagnosed from July 1, 2014 to May 31, 2019. The autotransplant is considered as a therapeutic line more, and all patients who did not receive the transplant were analyzed as if they had received it. The patients always receive some of the authorized treatments for their therapeutic line, according to the preferences of the responsible hematologist and the patient. After the induction phase, all the patients undergo stem-cell mobilization with granulocyte colony-stimulating factor.
The patients of the fixed treatment group (control group) receive up to six cycles of the consolidation treatment after transplantation if complete remission has not been achieved.
In the patients of the MRDI-driven group, patients continue treatment after transplantation to achieve complete remission with negative MRD and negative image, changing therapeutic line if not achieved with the prescribed treatment. In this group of the patients the treatment is stopped only when this degree of deep response is achieved, in whatever the treatment phase was.
Assessments The treatment response and disease progression are assessed according to the International Uniform Response Criteria for Multiple Myeloma, except that to consider the negative Minimal Residual Disease, a sensitivity level of 10-6 is required. In addition, it is considered negative image only if a Positron Emission Tomography/Computed Tomography (PET/CT) body and spinal and pelvic Nuclear Magnetic Resonance (NMR), are both negative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Younger than 76 years
- •Diagnosed with Multiple Myeloma from July 1, 2014 to May 31, 2019
- •Received some of the standard authorized treatments for their therapeutic line. Patients treated in clinical trials with treatments not yet authorized, for fifth or successive therapeutic lines are admitted.
- •Give informed consent
- •Fit patient
排除标准
- •Under 18 years old
- •Contraindication for bone marrow auto-transplantation
- •Therapeutic objective only palliative:
- •Another non-treatable neoplasm
- •Severe senile dementia
- •Significant comorbidity limiting life expectancy to less than 6 months
研究组 & 干预措施
MRDI-driven treatment
Patients continue treatment until complete remission with negative MRD and Image is achieved, changing the therapeutic line if this is not achieved with the prescribed treatment. In this group of patients, treatment is suspended only when this degree of profound response is reached, in any phase of treatment.
干预措施: Continued treatment adapted to the response (Other)
Conventional treatment
The patients of the conventional treatment group (control group) received six cycles of the induction traetment, bone marrow auto-transplantation, and consolidation treatment after transplantation if complete remission had not been achieved.
结局指标
主要结局
Average grade 3 or higher adverse events per patient
时间窗: Time elapsed from start of treatment to end of follow-up or patient death, whichever came first, assessed up to 120 months.
Number of grade 3 or higher adverse events in the group divided by the number of patients in the group
Overall Survival
时间窗: Time elapsed from start of treatment to end of follow-up or patient death, whichever came first, assessed up to 120 months.
Time from start of treatment to death from any cause
Progression Free Survival
时间窗: Time elapsed from start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Time elapsed from start of treatment until first documentation of disease progression or date of death from any cause, whichever came first.
Proportion of patients with serious adverse effects
时间窗: Time elapsed from start of treatment to end of follow-up or patient death, whichever came first, assessed up to 102 months.
Number of patients with any adverse event grade 3 or higher, divided by the total number of patients in the corresponding group
Annual incidence of grade 3 or higher adverse effects
时间窗: Time elapsed from start of treatment to end of follow-up or patient death, whichever came first, assessed up to 102 months.
Number of grade 3 or higher adverse events in the group divided by the sum of the years of observation of the group members
次要结局
未报告次要终点
研究者
Jose Enrique de la Puerta, MD
Principal Investigator
Hospital Galdakao-Usansolo