Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tufts Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Not yet recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Smoldering Multiple Myeloma
Additional Details

This study is based on results from two prior studies in which 4 of 36 patients with SMM and none of 14 patients with MGUS were found to have AL. The hypothesis that we test with this protocol is that patients with

  • (1) a pre-existing diagnosis of SMM, (2) free light chain (FLC) abnormalities, (3) IGLV genes associated with AL,(4) t(11;14) or gain 1q, and (5) NT-proBNP > 332pg/mL will have undiagnosed AL or risk of progression to AL.
We will study the potential for SMM, the FLC screen, AL-related IGLV gene use, t(11;14) or gain 1q cytogenetic abnormalities, and NT-proBNP > 332pg/mL to be the variables in a likelihood algorithm for AL.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama Hospital, Birmingham, Alabama



University of Alabama Hospital

Birmingham, Alabama, 35233

Cedars-Sinai Medical Center, Los Angeles, California



Cedars-Sinai Medical Center

Los Angeles, California, 90048

University of California, Irvine, Orange, California



University of California, Irvine

Orange, California, 92868

University of California, San Francisco, San Francisco, California



University of California, San Francisco

San Francisco, California, 94143

Weston, Florida



Cleveland Clinic Florida, Weston Hospital

Weston, Florida, 33331

Tufts Medical Center, Boston, Massachusetts



Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Denis Toskic, BS


Dana-Farber Cancer Institute, Boston, Massachusetts



Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Columbia University Medical Center, New York, New York



Columbia University Medical Center

New York, New York, 10032

Memorial Sloan Kettering Cancer Center, New York, New York



Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Atrium Health Levine Cancer Institute, Charlotte, North Carolina



Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28204

Durham, North Carolina



UNC Lineberger Comprehensive Cancer Center

Durham, North Carolina, 27705

Dallas, Texas



UT Southwestern, Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75390

Salt Lake City, Utah



University of Utah, Huntsman Cancer Hospital

Salt Lake City, Utah, 84112

VCU Medical Center, Richmond, Virginia



VCU Medical Center

Richmond, Virginia, 23219