NCT01838512进行中（未招募）不适用
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Bristol-Myers Squibb51 个研究点 分布在 6 个国家目标入组 2,555 人开始时间: 2012年6月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,555
- 试验地点
- 51
- 主要终点
- Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
研究概览
简要总结
The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice.
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
- •For RRMM participants who have received at least one prior line of therapy (LoT) for MM:
- •Have documented progression from a prior LoT
- •Participants who have initiated treatment with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
- •Combination of IMiD + PI
- •Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)
- •For NDMM participants receiving frontline therapy:
- •Eligible to receive frontline therapy for MM (no prior MM treatment)
- •Participants who have initiated treatment for MM with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
- •Combination of IMiD + PI
- •Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)
排除标准
- •Participants who are currently participating in a clinical trial for MM
- •Participants who are currently receiving treatment for primary cancer other than MM
- •Participants who are not willing or able to provide informed consent
- •Participants who are incarcerated
- •Participants under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
时间窗: Up to 8 years
Progression-Free Survival (PFS) for participants with NDMM
时间窗: Up to 8 years
Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)
时间窗: Up to 5 years
Progression-Free Survival (PFS) for participants with RRMM
时间窗: Up to 5 years
次要结局
- Healthcare resource utilization (HCRU) for participants with NDMM(From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 96 months)
- Incidence of Adverse Events (AEs) for participants with RRMM(Up to 5 years)
- Incidence of Adverse Events (AEs) for participants with NDMM(Up to 8 years)
- Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM(From study index date until the enrollment date, assessed up to 5 years)
- Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM(From study index date until the enrollment date, assessed up to 8 years)
- Healthcare resource utilization (HCRU) for participants with RRMM(From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 60 months)
- Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM(From start of initial therapy to questionnaire completion, assessed up to 8 years)
- Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM(From start of initial therapy to questionnaire completion, assessed up to 5 years)
- Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM(From start of initial therapy to questionnaire completion, assessed up to 8 years)
- Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM(From start of initial therapy to questionnaire completion, assessed up to 5 years)
- Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM(From start of initial therapy to questionnaire completion, assessed up to 8 years)
- Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM(From start of initial therapy to questionnaire completion, assessed up to 5 years)
研究者
研究点 (51)
Loading locations...
相似试验
已完成
3 期
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar StenosisLow Back PainLeg PainLumbar Spinal StenosisSpondylolisthesisNCT00405691Impliant, Ltd.450
已完成
不适用
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault ProlapseUrinary Incontinence, StressMixed IncontinenceVaginal Vault ProlapseNCT00223106Medtronic - MITG467
已完成
不适用
Coronary Crossing System in Patients With Coronary Chronic Total OcclusionsChronic Total Occlusion of Coronary ArteryNCT05813704Shanghai MicroPort Rhythm MedTech Co., Ltd.159
已完成
不适用
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)Coronary Artery CalcificationNCT05818098Shanghai MicroPort Rhythm MedTech Co., Ltd.189
招募中
不适用
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro ImplantNCT06657248Aesculap AG150