Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05361694|
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : June 9, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)|
|Actual Study Start Date :||April 12, 2022|
|Estimated Primary Completion Date :||July 1, 2027|
|Estimated Study Completion Date :||July 1, 2027|
Participants with MGUS or SMM
Participants with either Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SMM) will be followed for disease progression to active multiple myeloma (MM) for up to 5 years.
- Rate of progression to active Multiple Myeloma (MM) [ Time Frame: Up to 5 years ]The rate of progression to active multiple myeloma in participants with tumors with and without myeloma defining genomic events as evaluated by treating physician via clinical assessments (including low-input DNA whole-genome sequencing)
- Frequency of participant conversion from MGUS/SMM to Myeloma defining genomic events [ Time Frame: Up to 5 years ]As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
- Frequency of participant conversion from MGUS/SMM to associated progressive phenotype [ Time Frame: Up to 5 years ]As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
- Rate of participant conversion from MGUS/SMM to Myeloma defining genomic events [ Time Frame: Up to 5 years ]As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
- Rate of participant conversion from MGUS/SMM to associated progressive phenotype [ Time Frame: Up to 5 years ]As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05361694
|Contact: Carl Landgren, MDemail@example.com|
|United States, Florida|
|University of Miami Hospitals||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Carl Landgren, MD 305-243-6578 firstname.lastname@example.org|
|Principal Investigator: Carl Landgren, MD|
|Principal Investigator:||Carl Landgren, MD||University of Miami|
|Responsible Party:||University of Miami|
|Other Study ID Numbers:||
|First Posted:||May 5, 2022 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases