200 Participants Needed

Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

EE
MH
Overseen ByMei Huang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Research Team

KP

Krin Patel, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

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%

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo collection of blood samples every 6 months for 3 years. Additional tests such as biopsy, x-rays, PET/CT scans, and MRI scans may be conducted at the discretion of the treating physician.

3 years
6 visits (in-person) over 3 years

Follow-up

Participants are monitored every 6-12 months after the initial 3-year observation period to assess progression to multiple myeloma.

Ongoing
1-2 visits per year (in-person)

Treatment Details

Participant Groups
1Treatment groups
Experimental Treatment
Group I: Observational (biospecimen collection)Experimental Treatment2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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