Official Title
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
Brief Title
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions
Protocol ID
NCT05361694
Lead Sponsor
University of Miami
Brief Summary
The key aim of the study is to define the two biologically and clinically distinct
entities: progressive versus stable myeloma precursor conditions.
Study Period
-
Enrollment Count
1,000 participants
Eligibility Criteria
Inclusion Criteria:
1. 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
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.
3. Age greater than or equal to 18 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
5. The patient must be competent to sign an informed consent form.
Exclusion Criteria:
1. 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)
2. 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.
3. 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.
Filters
Multiple Myeloma
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
RECRUITING
ADULT
OLDER_ADULT