NCT06212323招募中不适用
Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of morbid progression events attributable to a plasma cell dyscrasia at two years, with morbid events defined as: death, renal injury that does not reverse, fracture, lytic bone lesion, AL Amyloidosis or plasma cell leukemia.
研究概览
简要总结
The purpose of this study is to define the natural history of high-risk smoldering myeloma in a modern cohort of patients undergoing close standard of care follow-up with diffusion weighted whole body magnetic resonance imaging.
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
- •Adult subject aged ≥ 18 years.
- •Diagnosis of smoldering myeloma as per the IMWG criteria, specifically:
- •Serum monoclonal protein (IgG or IgA) of 30g/L or greater per 24 hours or urinary monoclonal protein of 500mg or greater per 24 hours and/or
- •Clonal bone marrow plasma cells 10-59% with the absence of myeloma-defining events or amyloidosis
- •High-risk smoldering myeloma defined as two or more out of four of the following criteria:
- •M-spike greater than 2 g/dL
- •An involved/uninvolved free light chain ratio greater than 20
- •Bone marrow plasmacytosis greater than 20%
- •Presence of any of translocation (4;14), deletion 17p, deletion 13q or 1q gain by conventional cytogenetics/fluorescence in situ hybridization (FISH) studies) and/or
- •An IMWG SMM score of 9 or greater according to the IMWG risk model for smoldering multiple myeloma (SMM)
- •Diagnosis of high-risk SMM made within 365 days of enrollment in the study. Note: If a patient previously had MGUS or low/intermediate SMM- the date at which high-risk SMM was diagnosed would have to be within 365 days of enrollment in the study.
排除标准
- •Presence of any features that would meet diagnostic criteria for myeloma as per the IMWG Criteria
- •Presence of extramedullary plasmacytomas
- •Presence of any focal bone marrow lesions, or lytic bone lesions on imaging done prior to screening or on screening. However, presence of diffuse or patchy infiltration of the marrow (without any clear lesions) on MRI, will not be an exclusion criteria. Patients with 1 focal marrow lesion on MRI that is attributable to plasma cell dyscrasia, will be excluded from study, even if they do not meet criteria for myeloma. Patients with 1 focal marrow lesion can only be enrolled if the lesion does not appear to be related to myeloma, based on the judgement of the investigator. Use of restricted diffusion and ADC values can assist in ascertainment.
- •Creatinine clearance of less than 40ml/min.
- •Presence of AL Amyloidosis (the amount of workup necessary to exclude AL Amyloidosis is per the discretion of the treating investigator, however the investigator must attest that they do not believe AL Amyloidosis to be present at time of enrollment. Serum nt-PROBNP is recommended as part of evaluation in order to ascertain for cardiac amyloidosis).
- •Note: The Hgb cut-offs can vary between institutions (lower cut-off for Hgb University of Utah for men is a Hgb of 14.8, rendering a patient with Hgb of 12.7 as having a CRAB feature). If the Hgb is above 10g/dl but the patient meets the definition of anemia according to the IMWG criteria, by virtue of this being more than 2 g/dl below the limit of normal, the investigator can decide whether to call a patient being considered for screening as having multiple myeloma OR smoldering myeloma and allow enrollment on this study.
- •Given that the values used to define high-risk SMM can change, at time of enrollment, if utilizing at least 2/4 of the 2/20/20+cytogenetics criteria to enroll, participants should meet at least 2/4 of the 2/20/
- •If participants had met at least 2/4 previously at some timepoint but do not meet at least 2/4 currently, they cannot be enrolled in the study.
结局指标
主要结局
Incidence of morbid progression events attributable to a plasma cell dyscrasia at two years, with morbid events defined as: death, renal injury that does not reverse, fracture, lytic bone lesion, AL Amyloidosis or plasma cell leukemia.
时间窗: 2 years
Frequency and nature of progression events in a prospective cohort of patients with smoldering myeloma undergoing active surveillance with diffusion weighted whole body MRI
次要结局
- Change in the quality of life as measured by physical function domain on the PROMIS-29 (Patient-Reported Outcomes Measurement Information System), from baseline to the end of study at 24 months of follow-up.(2 years)
- Change in the quality of life as measured by pain interference domain on the PROMIS-29 (Patient-Reported Outcomes Measurement Information System), from baseline to the end of study at 24 months of follow-up.(2 years)
- Change in the quality of life as measured by anxiety domain on the PROMIS-29 (Patient-Reported Outcomes Measurement Information System), from baseline to the end of study at 24 months of follow-up.(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Biology and Genetics of Smouldering MyelomaSmouldering MyelomaMultiple MyelomaMGUSNCT05047107University College, London500
已完成
2 期
E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple MyelomaSmoldering MyelomaSmoldering Multiple MyelomaNCT02279394Dana-Farber Cancer Institute51
Unknown
不适用
Etiology of Multiple Myeloma: A Case-Control StudyMultiple MyelomaNCT00505999M.D. Anderson Cancer Center140
终止
2 期
UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete RemissionMultiple MyelomaNCT02128230University of Arkansas20
进行中（未招募）
不适用
Cohort Construction and Prognostic Model Construction for Multiple MyelomaMultiple MyelomaNCT06366802The First Affiliated Hospital of Soochow University1,000