NCT05361694招募中不适用
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Rate of progression to active Multiple Myeloma (MM)
研究概览
简要总结
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
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
- •Diagnosis of MGUS and SMM will be made in accordance with the clinical diagnostic criteria set forth by the 2014 International Myeloma Working Group (IMWG) Revised Criteria.2
- •The diagnoses will be confirmed by either serum/urine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests.
- •Age greater than or equal to 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •The patient must be competent to sign an informed consent form.
排除标准
- •A diagnosis of MM as defined as any patient with detectable M-protein in blood and/or urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage based on the Calcium Elevation, Renal Failure, Anemia, and Bone Disease (CRAB) criteria and/or myeloma-defining events.
- •Patients who have received previous therapy for MM.
- •Patients with known plasma cell or related lymphoid (e.g. lymphoplasmacytic lymphoma, Amyloid Light chain (AL) amyloidosis)
- •Confirmation of pathological diagnosis is required either from the initial pathology review report or review from the UM/SCCC Hematopathologist in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group (IMWG) or World Health Organization (WHO). Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the patient during sampling required for routine patient care or required testing on a University of Miami (UM) /Sylvester Comprehensive Cancer Center (SCCC) research protocol will be used for diagnosis.
- •Active symptomatic major organ disorder that would increase the risk of biopsy or other procedure, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
- •Active concomitant medical or psychological illnesses that may increase the risk to the patient or inability to obtain informed consent, at the discretion of the Principal Investigator.
- •Pregnant or breast-feeding women will not be eligible for any aspect of this protocol.
- •Prisoners will be excluded.
研究组 & 干预措施
Participants with MGUS or SMM
Participants with either Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SMM) will be followed for disease progression to active multiple myeloma (MM) for up to 5 years.
结局指标
主要结局
Rate of progression to active Multiple Myeloma (MM)
时间窗: Up to 5 years
The rate of progression to active multiple myeloma in participants with tumors with and without myeloma defining genomic events as evaluated by treating physician via clinical assessments (including low-input DNA whole-genome sequencing)
次要结局
- Frequency of participant conversion from MGUS/SMM to Myeloma defining genomic events(Up to 5 years)
- Frequency of participant conversion from MGUS/SMM to associated progressive phenotype(Up to 5 years)
- Rate of participant conversion from MGUS/SMM to Myeloma defining genomic events(Up to 5 years)
- Rate of participant conversion from MGUS/SMM to associated progressive phenotype(Up to 5 years)
研究者
Carl Ola Landgren, MD, PhD
Professor
University of Miami
研究点 (2)
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