RECRUITING
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Screening for AL Amyloidosis in Smoldering Multiple Myeloma
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.
Conditions:
🦠 Smoldering Multiple Myeloma
🗓️ Study Start (Actual) 1 May 2024
🗓️ Primary Completion (Estimated) 27 February 2029
✅ Study Completion (Estimated) 27 February 2029
👥 Enrollment (Estimated) 400
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Los Angeles, California, United States
📍 Orange, California, United States
📍 San Francisco, California, United States
📍 Weston, Florida, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Charlotte, North Carolina, United States
📍 Durham, North Carolina, United States
📍 Dallas, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Richmond, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients 40 years of age and older
    • * diagnosed with Smoldering Multiple Myeloma
    • * 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
Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 April 2024
  • First Submitted that Met QC Criteria 10 April 2024
  • First Posted 15 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 July 2024
  • Last Update Posted 19 July 2024
  • Last Verified July 2024
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