Connect® MM- The Multiple Myeloma Disease Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 3,011
- 试验地点
- 491
- 主要终点
- Participant medical history
研究概览
简要总结
The purpose of the Connect® MM Registry is to explore the natural history and real world management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide unique insights into the management of MM and the impact of this hematologic disorder on patients.
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
- •Cohort 1 and 2
- •Newly diagnosed with symptomatic MM within 2 months of enrollment in Connect® MM registry
- •Age ≥18 years
- •Willing and able to provide signed informed consent
- •Agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel
- •Received 1L therapy for symptomatic active MM and subsequently has evidence of disease progression. Prior 1L MM treatment received, including anti-myeloma therapy, transplant, chemotherapy, radiation, and surgery, must be known.
- •Initiated or intends to initiate 2L systemic therapy for MM after the first documented relapsed/refractory date (i.e. 1L PD).
- •Enrollment date must be within 90 days of start date (or intended start date) of 2L systemic therapy.
排除标准
- •Cohort 1 and 2
- •Patient's 1L MM treatment was for smoldering MM or MGUS, and not for symptomatic MM
- •Currently active in any MM Registry, including but not limited to, the Connect® MM registry or another Celgene/BMS-Sponsored registry.
- •Patients who have discontinued from Connect® MM or another Celgene/BMS-Sponsored registry could be considered for enrollment in Cohort 3, if inclusion and exclusion criteria are met.
- •Currently enrolled or intending to enroll within 90 days in any interventional clinical trial in which any treatment is an investigational product that cannot be identified
研究组 & 干预措施
Cohort 1: Patients enrolled between Sep 2009 and Nov 2011
Newly diagnosed multiple myeloma patients enrolled between Sep 2009 and Nov 2011.
干预措施: First-line therapy (Other)
Cohort 2: Patients enrolled between December 2012 and mid-2016
Newly diagnosed multiple myeloma patients enrolled between Dec 2012 and mid-2016
干预措施: First-line therapy (Other)
Cohort 3: Patients enrolled from 2023
Relapsed/Refractory multiple myeloma patients receiving second-line therapy
干预措施: Second-line Multiple Myeloma treatments (Drug)
结局指标
主要结局
Participant medical history
时间窗: Baseline
Participant disease response assessment results
时间窗: Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Participant baseline demographics
时间窗: Baseline
Number of participants enrolled in a clinical trial
时间窗: Baseline, every 3-months up to 16 years or date of early discontinuation
Cohort 1 and 2 only
Participant Multiple Myeloma diagnosis information
时间窗: Baseline
Participant Multiple Myeloma treatment history
时间窗: Baseline
Multiple Myeloma-related supportive concomitant medications and procedures
时间窗: Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Occurance of second primary malignancy
时间窗: Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
Lines of therapy prescribed
时间窗: Baseline, every 3-months up to 5 years (Cohort 3), or up to 16 years (Cohort 1 & 2), or date of early discontinuation
次要结局
- Number of participants that have received stem cell transplant(Baseline, and every 3-months up to 5 years or date of early discontinuation)
- Participant EuroQol-5 Dimensions (EQ-5D) questionnaire results(Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation)
- Participant participant Adverse Events (AEs)(Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation)
- Participant COVID-19 infection and vaccination status(Baseline, and every 3-months up to 5 years or date of early discontinuation)
- Treating clinician response to social support questionnaire(Baseline, and every 3-months up to 5 years or date of early discontinuation)
- Number of hospitalization or emergency room visits(Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation)
- Cause of death(Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2) or date of early discontinuation)
- Participant socioeconomic status(Baseline)
- Participant Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire results(Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation)
- Participant Visual Analogue Score (VAS) questionnaire results(Baseline, every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation)
- Participant participant survival status(Every 3-months up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2), or date of early discontinuation)
- Reason for registry discontinuation(Date of early discontinuation assessed up to 5 years (Cohort 3) or up to 16 years (Cohort 1 and 2))
- Reason for treatment initiation or discontinuation(Baseline, and every 3-months up to 5 years or date of early discontinuation)
- Treating clinician response to frailty questionnaire(Baseline, and every 3-months up to 5 years or date of early discontinuation)
- Participant Brief Pain Inventory (BPI) questionnaire results(Baseline, and every 3-months up to 5 years or date of early discontinuation)
- Participant response to social support questionnaire(Baseline, and every 3-months up to 5 years or date of early discontinuation)