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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02726750
Other study ID # PA15-0575
Secondary ID NCI-2020-07336PA
Status Recruiting
Phase
First received
Last updated
Start date December 14, 2015
Est. completion date April 30, 2026

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Mei Huang
Phone 713-745-9901
Email mhuang3@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

PRIMARY OBJECTIVE: I. To determine the rate of progression to multiple myeloma after 3 years of follow up. SECONDARY OBJECTIVES: I. To describe baseline patient characteristics and clinical variables. II. To identify molecular and genetic correlates that may predict for progression to multiple myeloma (MM). OUTLINE: Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, positron emission tomography (PET)/computed tomography (CT) scans, and/or magnetic resonance imaging (MRI) scans to check the status of disease at the discretion of the treating physician. After completion of 3 years on study, patients are followed up every 6-12 months thereafter.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo collection of blood samples
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Molecular profiling analysis of patients who develop MM Analysis will include whole exome sequencing and gene expression profiling and cellular (including flow cytometry) profiling using bone marrow and peripheral blood samples. 3 years
Other Immune characterization of patients who develop MM Analysis will include cell surface and functional studies of dendritic, T-, B-, natural killer (NK)- and NKT-cells using peripheral blood samples. 3 years
Other Immune characterization of patients who develop MM Analysis will include cell surface and functional studies of dendritic, T-, B-, NK- and NKT-cells using bone marrow samples. 3 years
Primary Rate of progression to multiple myeloma (MM) Kaplan-Meier method will be used to estimate time to MM progression. Log-rank test will be used to evaluate the difference in rate of progression between/among patient groups. 3 years
Primary Progression free survival Will be estimated using the Kaplan-Meier method. Log-rank test will be used to evaluate the difference in rate of progression free survival between/among patient groups. 3 years
Primary Overall survival Will be estimated using the Kaplan-Meier method. Log-rank test will be used to evaluate the difference in rate of overall survival between/among patient groups. 3 years
Secondary Baseline patient characteristics and clinical variables Summary statistics including mean, standard deviation, median, and range will be provided for continuous variables. Frequency counts and percentages will be used to summarize categorical variables. Baseline
Secondary Molecular and genetic profile analysis Will study the correlation of molecular and genetic profiles with time to MM progression. 3 years
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