Hunting for clues: study seeks to predict myeloma before it starts
NCT ID NCT02726750
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This observational study follows 200 people with early blood conditions (MGUS or smoldering myeloma) that sometimes turn into multiple myeloma. Researchers will track age, blood protein levels, bone marrow cells, genes, and bone health to find patterns that predict progression. No treatments are tested; the goal is to improve future risk assessment and care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2015
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with monoclonal gammopathy of unknown significance and/or smoldering multiple myeloma
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with monoclonal gammopathy of unknown significance. Both criteria must be met: * Serum monoclonal protein \< 3 g/dL or urinary monoclonal protein \< 500 mg per 24 hours and clonal bone marrow plasma cells \< 10% * Absence of myeloma defining events or amyloidosis * Patients with smoldering multiple myeloma. Both criteria must be met: * Serum monoclonal protein \>= 3 g/dL or urinary monoclonal protein \>= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60% * Absence of myeloma defining events or amyloidosis Exclusion Criteria: * Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following * Hypercalcemia: serum calcium \> 0.25 mmol/L (\> 1 mg/dL) higher than the upper limit of normal or \> 2.75 mmol/L (\> 11 mg/dL) * Renal Insufficiency: creatinine clearance \< 40 ml/min or serum creatinine \> 2 mg/dL * Anemia: hemoglobin value \< 10 g/dL or 2 g/dL \< normal reference * Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\[F-18\] fluoro-D-glucose positron emission tomography CT (PET-CT) * Clonal bone marrow plasma cell percentage \>= 60% * Involved:uninvolved serum free light chain ratio \>= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom \[UK\]) * \> 1 focal lesions on magnetic resonance imaging (MRI) studies (each focal lesion must be 5 mm or more in size) * Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies * Bisphosphonates are permitted * Radiotherapy is not permitted * Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted * Plasma cell leukemia * Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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