Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

NCT02726750 | Recruiting

• 2 other identifiers: PA15-0575NCI-2020-07336
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoldering Plasma Cell Myeloma; Monoclonal Gammopathy of Undetermined Significance

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Baseline patient characteristics and clinical variables

  Baseline

• Molecular and genetic profile analysis

  3 years

Other Outcomes (3)

• Molecular profiling analysis of patients who develop MM

  3 years

• Immune characterization of patients who develop MM

  3 years

• Immune characterization of patients who develop MM

  3 years

Study Arms (1)

Observational (biospecimen collection)

Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, PET/CT scans, and/or MRI scans to check the status of disease at the discretion of the treating physician.

Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Observational (biospecimen collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone marrow

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Neoplasms

Study Officials

• Krin Patel, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Huang

CONTACT

713-745-9901; mhuang3@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 4, 2016
• Study Start: December 14, 2015
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)