Clinical Trial: Predictors of Progression to Myeloma in Patients With MGUS or SMM at MD Anderson

Why do some MGUS or smoldering myeloma patients without symptoms progress from these early conditions to active myeloma? Myeloma researcher Elisabet Manasanch, MD of the MD Anderson Cancer Center is running a study to better understand factors that relate to progression. Questions she wants answered include: Why do some patients progress to actual myeloma? Is there something we can do about progression? Who is more likely to progress?

Potential markers that could affect progression include:  

• Age
• Level of proteins in the blood
• Percent of abnormal blood cells in the bone marrow
• Genes in the abnormal myeloma cells
• Bone abnormalities

How the Study Works

In the study, patients at MD Anderson will donate samples and take imaging tests to assess the progression of the disease:

• Collection of blood samples every 6 months for a period of 3 years
• Collection of bone marrow biopsy samples if needed
• Imaging such as x-rays, PET (positron emission tomography), CT Scans (computed tomography), and MRI (magnetic resonance imaging) scans

After 3 years, patients will be followed every 6-12 months thereafter.

Key Study Markers

The study will first look at the following primary outcomes over the 3-year period: 

• Rate of progression to multiple myeloma (MM) 
• Progression-free survival 
• Overall survival 

Secondarily, the study will look at these additional outcomes over the 3-year period: 

• Baseline patient characteristics and clinical variables: age, gender, race, ethnicity, proteins in the blood, imaging results, bone marrow biopsy results, etc.
• Molecular and genetic profile analysis (Time Frame: 3 years) This is through bone marrow biopsy samples and genetic testing such as FISH, flow cytometry or cytogenetics.
• Will study the relation of molecular and genetic profiles with time to MM progression.

Other outcomes will be reviewed that include: 

• Molecular profiling analysis of patients who develop MM (Time Frame: 3 years).  The analysis will use bone marrow and peripheral blood samples.
• Immune characterization of patients who develop MM (Time Frame: 3 years). The analysis will use peripheral blood samples.

To learn more about this clinical trial on HealthTree or to get help joining this study, please call 1-800-709-1113. 

Resources

• If you need a tool to help you track your myeloma labs, click here to use HealthTree Cure Hub
• Learn about the importance of clinical trials here
• More information about smoldering myeloma can be found here