NCT02726750 · M.D. Anderson Cancer Center
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
What this study is about
The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not.
View original scientific description
The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations