Observational study on monoclonal gammopathies leading to myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify markers that predict the progression of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to multiple myeloma. Over a three-year period, patients will have blood samples collected every six months and may undergo various imaging tests to monitor disease status. The study will analyze clinical and genomic data to validate predictors of disease progression, enhancing future clinical practices.

Why it matters

Who can join: the full rules

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 it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Krin Patel, MD — M.D. Anderson Cancer Center
• Study coordinator: Mei Huang
• Email: mhuang3@mdanderson.org
• Phone: 713-745-9901

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Frequency of GBA and PSAP Gene Variants in Patients with MM or MGUS

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• Exploring the effects of a plant-based diet and supplements on smoldering multiple myeloma

  This study is testing whether a plant-based diet and certain supplements can change butyrate levels in the stool of people with smoldering multiple myeloma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.