Understanding different types of multiple myeloma precursor conditions
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
This study is trying to tell the difference between two early stages of multiple myeloma, smoldering multiple myeloma and monoclonal gammopathy of undetermined significance, to better understand how they progress or stay stable.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05361694 on ClinicalTrials.gov |
What this trial studies
This observational study aims to differentiate between progressive and stable precursor conditions of multiple myeloma, specifically focusing on smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance (MGUS). The study will utilize established clinical diagnostic criteria and laboratory tests to confirm diagnoses and assess the biological and clinical characteristics of these conditions. By analyzing these distinct entities, the research seeks to enhance understanding of their progression and stability.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with MGUS or SMM according to the 2014 International Myeloma Working Group criteria.
Not a fit: Patients with a confirmed diagnosis of multiple myeloma or those who have previously received treatment for the condition will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient stratification and management strategies for individuals at risk of developing multiple myeloma.
How similar studies have performed: While this study addresses a critical area in multiple myeloma precursor conditions, similar studies have not been widely reported, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- University of Miami Hospitals — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Carl Landgren, MD — University of Miami
- Study coordinator: Carl Landgren, MD
- Email: col15@miami.edu
- Phone: 3052436578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.