Actively Recruiting
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-21
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) who have no symptoms to understand why some develop multiple myeloma while others do not. The study aims to find markers such as age, blood protein levels, abnormal blood cell percentages, genetic information, and bone abnormalities that may help predict disease progression. This observational research is sponsored by the M.D. Anderson Cancer Center. Participants will have blood samples taken every six months for three years to collect data. Additional tests like biopsies, X-rays, PET/CT scans, and MRI scans may be done based on the treating physician's judgment to monitor disease status. After three years, patients will continue to be followed up every six to twelve months to observe long-term outcomes. During the study, researchers will assess patient characteristics, clinical variables, and molecular and genetic profiles. The main outcomes include measuring the rate of progression to multiple myeloma, progression-free survival, and overall survival over three years. Patients will be monitored regularly through blood tests and imaging as needed, with ongoing follow-up after the initial three-year period to track their health status.
CONDITIONS
Brief Title
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of monoclonal gammopathy of unknown significance with serum monoclonal protein less than 3 g/dL or urinary monoclonal protein less than 500 mg per 24 hours and clonal bone marrow plasma cells less than 10%
- No signs of myeloma defining events or amyloidosis for MGUS
- Diagnosis of smoldering multiple myeloma with serum monoclonal protein 3 g/dL or higher or urinary monoclonal protein 500 mg or higher per 24 hours and/or clonal bone marrow plasma cells between 10% and 60%
- No signs of myeloma defining events or amyloidosis for SMM
You will not qualify if you...
- Presence of myeloma defining events or malignancy biomarkers such as hypercalcemia, renal insufficiency, anemia, bone lesions, clonal bone marrow plasma cells 60% or higher, involved:uninvolved serum free light chain ratio 100 or higher, or more than one focal lesion on MRI
- Prior or current systemic treatment for asymptomatic monoclonal gammopathies except bisphosphonates
- Radiotherapy for asymptomatic gammopathies
- Diagnosis of plasma cell leukemia
- Uncontrolled illnesses including active infection or psychiatric illness/social situations that would affect study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 years
Participants undergo collection of blood samples every 6 months for 3 years to monitor disease status. Additional assessments such as biopsy, x-rays, PET/CT scans, and MRI scans may be performed at the discretion of the treating physician to check disease status.
Visits every 6 months for blood sample collection; additional imaging or biopsy visits as needed
Duration - Variable, after 3 years
After completing 3 years of monitoring, participants are followed up every 6 to 12 months to observe disease progression and overall health.
Visits every 6 to 12 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mei Huang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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