Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions

Официальное название

Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)

Обзор

The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.

Первичные конечные точки

• Rate of progression to active Multiple Myeloma (MM) [Срок оценки: Up to 5 years]

Вторичные конечные точки (4)

• Frequency of participant conversion from MGUS/SMM to Myeloma defining genomic events [Срок оценки: Up to 5 years]
• Frequency of participant conversion from MGUS/SMM to associated progressive phenotype [Срок оценки: Up to 5 years]
• Rate of participant conversion from MGUS/SMM to Myeloma defining genomic events [Срок оценки: Up to 5 years]
• Rate of participant conversion from MGUS/SMM to associated progressive phenotype [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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 0-3.
• The patient must be competent to sign an informed consent form.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Miami Hospitals — Miami

Идентификаторы

NCT: NCT05361694 · 20220067

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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