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

NCT ID: NCT05361694

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2027-07-01

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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Landgren, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Hospitals

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carl Landgren, MD

Role: CONTACT

col15@miami.edu

3052436578

Facility Contacts

Carl Landgren, MD

Role: primary

col15@miami.edu

305-243-6578

Other Identifiers

20220067

Identifier Type: -

Identifier Source: org_study_id