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Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)

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ClinicalTrials.gov Identifier: NCT05361694
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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.


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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
Study Population
Adult participants diagnosed with MGUS or SMM.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Carl Landgren, MD 3052436578 col15@miami.edu

Locations
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United States, Florida
University of Miami Hospitals Recruiting
Miami, Florida, United States, 33136
Contact: Carl Landgren, MD    305-243-6578    col15@miami.edu   
Principal Investigator: Carl Landgren, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Carl Landgren, MD University of Miami
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Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT05361694    
Other Study ID Numbers: 20220067
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Precancerous Conditions