Clinical Outcome of Ixazomib (NINLARO®) Based Regimens in Chinese Patients With Multiple Myeloma Previously Receiving a Bortezomib/Carfilzomib-Based (re)Induction Regimen in Clinical Setting of Real World: An Open-Label, Single-Arm, Multicenter, Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 20
- 主要终点
- Progression Free Survival (PFS) at 24 Months
研究概览
简要总结
The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib/carfilzomib -based to an Ixazomib-based treatment.
详细描述
This is a non-interventional, prospective study of participants with multiple myeloma (MM). Participants will be treated with ixazomib based regimens until progression or unacceptable toxicity leading to a discontinuation or change in regimen, for a maximum of 26 cycles (24 months) (as per NINLARO® label) in real world clinical setting.
The study will enroll approximately 80 participants. The data will be collected prospectively in medical charts and will be recorded into electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort:
• Participants with MM
This multi-center trial will be conducted in China. The overall time for data collection in the study will be 24 months. Participants will be followed once every 3 months for a period not exceeding 24 months, ending 12 months after the last participant's enrollment unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who was first diagnosed or first relapse MM participants using IMWG 2016 criteria.
- •Diagnosed with multiple myeloma using IMWG 2016 criteria and must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.
- •a. Stem cell harvest and mobilization regimen is acceptable if clinically indicated. But must first be confirmed by the Takeda Medical Monitor.
- •Who received bortezomib/carfilzomib-based triple-drug regimens as frontline treatment, including bortezomib+cyclophosphamide+dexamethasone (VCD), bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD), bortezomib+pomadomide+dexamethasone (VPD), or carfilzomib+lenalidomide+dexamethasone (KRD), carfilzomib+thalidomide+dexamethasone (KTD), carfilzomib+pomalidomide+dexamethasone (KPD).
- •Must achieve at least partial response (PR) as defined by IMWG criteria after bortezomib/carfilzomib-based initial therapy.
- •Eastern Cooperative Oncology Group (ECOG) 0-2.
排除标准
- •Received a bortezomib/carfilzomib-based triple-drug regimens as initial therapy less than 2 cycles.
- •Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- •Have documented diagnosis of other cancers prior to the diagnosis of MM, excluding squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, which is considered cured with minimal risk of recurrence within 3 years.
- •Has >=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
- •Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
- •Have gastrointestinal (GI) disease or procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
- •Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.
研究组 & 干预措施
Participants With Multiple Myeloma (MM)
Participants diagnosed with MM (newly diagnosed multiple myeloma [NDMM] and first relapse multiple myeloma [FRMM]) using International Myeloma Working Group (IMWG) criteria who received a bortezomib/carfilzomib-based triple-drug regimens for more than 2 cycles as initial therapy, achieved at least partial response (PR) as defined by IMWG criteria, and are ready to start receiving an ixazomib containing therapy prescribed by their treating physician will be observed prospectively for 24 months.
干预措施: No intervention (Other)
结局指标
主要结局
Progression Free Survival (PFS) at 24 Months
时间窗: From the date of first administration of ixazomib therapy to the date of first documentation of PD or death, lost to follow-up, whichever occurs first (up to 24 months)
PFS:time date of first administration of ixazomib therapy to date of first documentation of progressive disease(PD)/death,lost to follow-up,whichever occurs first as per IMWG 2016 Response Criteria.PD:increase of 25 percent(%) from lowest confirmed response value in any one/more of following:Serum and Urine M-protein only in participants without measurable serum and urine M-protein levels,difference between involved/uninvolved free light chain (FLC) levels(absolute increase greater than(\>)10 milligram per deciliter \[mg/dL\]),and without measurable involved FLC levels, bone marrow plasma-cell% irrespective of baseline status (absolute increase must be ≥10%); appearance of new lesions, ≥50% increase from nadir in SPD of \>1 lesion/ ≥50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter \[mcL\]) if this is the only measure of disease. It will be analyzed using Kaplan-Meier method.
次要结局
- Number of Participants Categorized Based on Reason for Discontinuation of Ixazomib Therapy(Up to 24 months)
- Time to Next Treatment (TTNT)(From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months))
- Percentage of Participants Achieving Very Good Partial Response (VGPR)(Up to 24 months)
- Percentage of Participants Achieving Complete Response (CR)(Up to 24 months)
- Percentage of Participants Achieving Stringent Complete Response (sCR)(Up to 24 months)
- Duration of Ixazomib Therapy (DOT)(Up to 24 months)
- Duration of CR(Up to 24 months)
- Overall Survival (OS)(Up to 24 months)
- Health-related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20)(Up to 24 months)
- HRQOL Based on EORTC QLQ-C30(Up to 24 months)
- Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Up to 24 months)
- Number of Participants Categorized Based on Healthcare Resource Utilization(Up to 24 months)
- Number of Participants Categorized Based on Reason for Dose Reduction of Ixazomib Therapy(Up to 24 months)
- Number of Participants Categorized Based on Reason for Interruption of Ixazomib Therapy(Up to 24 months)
- Relative Dose Intensity (RDI)(Up to 24 months)
- Number of Participants who Experience at Least one Adverse Event (AE)(Up to 24 months)
- Number of Participants Categorized Based on Occurrence of Second Primary Malignancies (SPM)(Up to 24 months)