Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

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.

Conditions

Monoclonal Gammopathy of Undetermined Significance, Smoldering Plasma Cell Myeloma

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Study Overview

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Study Details

Study overview

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.

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

Condition
Monoclonal Gammopathy of Undetermined Significance
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Krin Patel, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2026-04-30