Following people with early myeloma signs to see how the condition changes
Studies people with early myeloma signs to tell progressing and stable forms apart.
Plain-language title generated from the registry record
Registry title: Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions
Key facts
- Where
- Miami, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a myeloma precursor condition, either MGUS or smoldering myeloma, who do not have active multiple myeloma.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- MGUS or smoldering multiple myeloma (SMM), diagnosed by the 2014 IMWG criteria and confirmed by blood or urine tests or a bone marrow biopsy. Not active multiple myeloma.
- Earlier treatment
- People who have already had treatment for multiple myeloma cannot join.
Main reasons for not taking part
- Multiple myeloma with signs of organ damage (CRAB criteria or myeloma-defining events)
- Earlier treatment for multiple myeloma
- Related blood cancers such as lymphoplasmacytic lymphoma or AL amyloidosis
- Serious active heart, lung or other organ disease that raises the risk of a biopsy or procedure
- Pregnant or breast-feeding women, and prisoners
Read by machine on 9 November 2026.
Where in United States
- University of Miami HospitalsMiami, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Miami
- Trial code
- NCT05361694
- Record updated
- 9 April 2026
- Original description
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.Read full original descriptionShow less
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
Inclusion: 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.
Exclusion: 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; 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).