Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

ConditionsMonoclonal Gammopathy of Undetermined Significance Smoldering Plasma Cell Myeloma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial population

Patients with monoclonal gammopathy of unknown significance and/or smoldering multiple myeloma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Biospecimen Collection
Procedure/Surgery
Undergo collection of blood samples
Laboratory Biomarker Analysis
Other intervention
Correlative studies

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Observational (biospecimen collection)2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

3 years

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.

Time frame

3 years

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.

Time frame

3 years

Secondary outcomes

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.

Time frame

Baseline

Molecular and genetic profile analysis

Will study the correlation of molecular and genetic profiles with time to MM progression.

Time frame

3 years

Other outcomes

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.

Time frame

3 years

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.

Time frame

3 years

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.

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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