Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT02726750

Conditions

Monoclonal Gammopathy of Undetermined Significance

Smoldering Plasma Cell Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Laboratory Biomarker Analysis

Study Details

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

Monoclonal Gammopathy of Undetermined Significance

Smoldering Plasma Cell Myeloma

Study ID

NCT02726750

Start date

Dec 14, 2015

Status verified date

Apr, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • Rate of progression to multiple myeloma (MM) [ Time Frame: 3 years ]
  • Progression free survival [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Mei Huang

713-745-9901mhuang3@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Mei Huang

713-745-9901mhuang3@mdanderson.org

Principal Investigator:

Krina Patel, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-21.