Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Tufts Medical Center
- Study ID
- NCT06365060
- Status
- Recruiting
Conditions
- Smoldering Multiple Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- May 1, 2024
- Status verified
- Aug 2025
- Primary completion
- Feb 27, 2029
- Completion
- Feb 27, 2029
Study Design
- Enrollment
- 400 participants (estimated)
Primary Outcome Measure
Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study. [ Time Frame: 5 years ]
Central Contacts
- Raymond Comenzo, MD617-636-6454
- Denis Toskic, BS617-636-5907
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama Hospital | Birmingham | Alabama | 35233 | Susan Bal, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Robert Vescio, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Tom Martin, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Florida, Weston Hospital | Weston | Florida | 33331 | Chakra Chaulagain, MD (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Raymond Comenzo, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University Irving Medical Center | New York | New York | 10032 | CUIMC Navigators Suzanne Lentzsch, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Bayley Axelrod Heather Landau, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Levine Cancer Institute | Charlotte | North Carolina | 28204 | Cindy Varga, MD (PRINCIPAL_INVESTIGATOR) |
| UNC Lineberger Comprehensive Cancer Center | Durham | North Carolina | 27705 | Sascha Tuchman, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Naresh Bumma, MD (PRINCIPAL_INVESTIGATOR) |
| UT Southwestern, Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | Larry Anderson, MD (PRINCIPAL_INVESTIGATOR) |
| University of Utah, Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | Amandeep Godara, MD (PRINCIPAL_INVESTIGATOR) |
| VCU Medical Center | Richmond | Virginia | 23219 | Hashim Mann, MD (PRINCIPAL_INVESTIGATOR) |
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