NCT06365060 Screening for AL Amyloidosis in Smoldering Multiple Myeloma
| NCT ID | NCT06365060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tufts Medical Center |
| Condition | Smoldering Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2029-02-27 |
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 400 participants in total. It began in 2024-05-01 with a primary completion date of 2029-02-27.
⚠ 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
In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm.
Eligibility Criteria
Inclusion Criteria: * Patients 40 years of age and older * diagnosed with either Smoldering Multiple Myeloma or a Monoclonal Gammopathy * dFLC greater than 23 mg/L * abnormal FLC ratio * If the patient has an eGFR less than 50 mL/min/1.73m2, the FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criterion. Exclusion Criteria: * Patients younger than 40 years of age are not eligible * Patients with a previous finding of amyloid in other biopsies will not be included * Adults unable to consent are not eligible, including the cognitively impaired Pregnant women, pregnant minors, minors (i.e., individuals who are not yet adults), wards of the state, non-viable neonates, neonates of uncertain viability, and prisoners are not eligible
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06365060 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Smoldering Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06365060 currently recruiting?
Yes, NCT06365060 is actively recruiting participants. Contact the research team at raymond.comenzo@tuftsmedicine.org for enrollment information.
Where is the NCT06365060 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, San Francisco, United States, Weston, United States and 9 additional locations.
Who is sponsoring the NCT06365060 clinical trial?
NCT06365060 is sponsored by Tufts Medical Center. The trial plans to enroll 400 participants.