Observational study on monoclonal gammopathies leading to myeloma
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma (ORIGIN Study)
This study is trying to find out if certain markers in blood samples can help predict when people with MGUS or smoldering myeloma might develop full-blown multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02726750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify markers that predict the progression of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to multiple myeloma. Over a three-year period, patients will have blood samples collected every six months and may undergo various imaging tests to monitor disease status. The study will analyze clinical and genomic data to validate predictors of disease progression, enhancing future clinical practices.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with MGUS or SMM who meet specific clinical criteria and are asymptomatic.
Not a fit: Patients who have evidence of myeloma defining events or other biomarkers of malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and personalized treatment strategies for patients with MGUS and SMM.
How similar studies have performed: While there have been studies on MGUS and SMM, this specific approach focusing on molecular and genetic correlates is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Krin Patel, MD — M.D. Anderson Cancer Center
- Study coordinator: Mei Huang
- Email: mhuang3@mdanderson.org
- Phone: 713-745-9901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.