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

NCT05361694 | Recruiting

• 1 other identifier: 20220067
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.

Conditions

Monoclonal Gammopathy of Undetermined Significance; Multiple Myeloma; Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Rate of progression to active Multiple Myeloma (MM)

  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)

  Up to 5 years

Secondary Outcomes (4)

• Frequency of participant conversion from MGUS/SMM to Myeloma defining genomic events

  Up to 5 years

• Frequency of participant conversion from MGUS/SMM to associated progressive phenotype

  Up to 5 years

• Rate of participant conversion from MGUS/SMM to Myeloma defining genomic events

  Up to 5 years

• Rate of participant conversion from MGUS/SMM to associated progressive phenotype

  Up to 5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with MGUS or SMM.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospitals

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia

Study Officials

• Carl Landgren, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Landgren, MD

CONTACT

3052436578; col15@miami.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 5, 2022
• Study Start: April 12, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)