NCT02726750 Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
| NCT ID | NCT02726750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Monoclonal Gammopathy of Undetermined Significance |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2015-12-14 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2015-12-14 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Krin Patel, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT02726750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Monoclonal Gammopathy of Undetermined Significance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02726750 currently recruiting?
Yes, NCT02726750 is actively recruiting participants. Contact the research team at mhuang3@mdanderson.org for enrollment information.
Where is the NCT02726750 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT02726750 clinical trial?
NCT02726750 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Krin Patel, MD at M.D. Anderson Cancer Center. The trial plans to enroll 200 participants.