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Understanding Progressive vs. Stable Myeloma Precursor Conditions

This study is looking at people with Multiple Myeloma (a type of blood cancer), Smoldering Multiple Myeloma, or Monoclonal Gammopathy of Undetermined Significance (MGUS – a condition that can sometimes lead to Multiple Myeloma). The main goal is to understand what makes some of these conditions progress to active Multiple Myeloma, while others remain stable. Researchers will follow participants for up to five years to see how many develop active Multiple Myeloma. This is an observational study, meaning there are no specific interventions or drugs being tested. You could be eligible if you are 18 or older and have one of these diagnoses, confirmed by specific lab tests.

Study design
This is an observational study with a planned enrollment of 1000 participants. It aims to define progressive versus stable myeloma precursor conditions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure the rate of progression to active Multiple Myeloma.

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NCT05361694

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

Recruiting
Not specifiedAges 18+Observational
University of Miami
~1,000 participants
Updated 2026-04-09 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of progression to active Multiple Myeloma (MM)
Measured over Up to 5 years

Conditions

Multiple Myeloma
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance

Explore related trials

Monoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple Myeloma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Carl Landgren, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Carl Landgren, MD
[email protected]
3052436578
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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Rate of progression to active Multiple Myeloma (MM)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)