A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early

Overview

This diagnostic trial seeks to help patients with smoldering multiple myeloma (SMM) take control of monitoring their disease. Roughly 50% of patients with SMM will progress to active disease within 5 years from diagnosis, 7% of whom will progress to light chain amyloidosis (AL). AL is a disease where plasma cells produce light chains that misfold and can accumulate throughout the body and cause organ dysfunction. AL is frequently overlooked as a diagnosis, which allows more time for harmful proteins to build up in different organs, making the disease much harder to treat. One of the most effective ways you can take control of your disease is taking active measures to catch any signs of progression as early as possible.

This observational study will enroll up to 200 smoldering multiple myeloma patients with lambda light chain involvement to study the risk of progressing to AL amyloidosis from smoldering multiple myeloma. To be eligible subjects must have lambda light chain involvement (heavy chain type does not matter), a difference between lambda and kappa light chains (dFLC) of greater than 23 mg/L, a kappa / lambda ratio of less than 0.26, and must be based in the United States. Subjects must consent to sharing their myeloma medical records for review and, if they are found eligible, to sending a one-time donation of blood (and whenever available of bone marrow too) to Tufts Medical Center in Boston. Shipping kits and shipping labels will be provided to participants and to their local physicians.

Blood and marrow cells from each patient will be screened in our laboratory for the presence of light chain genes commonly associated with AL amyloidosis. Participants will be told the results of the testing done at Tufts and of the relative risk of AL amyloidosis. If the risk is high, both participants and their physicians will be contacted and advised regarding diagnostic testing. Participants will also be contacted every few months in follow up.

SparkCures ID 811
Trial Phase Observational Trial
Enrollment 200 Patients
Trial Sponsors
  • Tufts Medical Center
NCT Identifier

NCT02741999

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patients diagnosed with λ LC SMM with dFLC greater than 23mg/L or κ::λ free LC ratios below normal. Subjects must be able to share their medical records and ship us bone marrow and blood samples.

Exclusion Criteria:

  • Patients with monoclonal gammopathy of undetermined significance (MGUS), kappa LC SMM or active myeloma will not be included. And patients who are unable to send us blood and marrow for any reason will not be eligible.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Tufts Medical Center Cancer Center

Boston, MA

Massachusetts
Tufts Medical Center Cancer Center

Boston, MA

Resources

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