NCT05361694 · University of Miami
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions
(TRANSFORMM)
What this study is about
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
View original scientific description
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations