PROFAST Intervention in Precursor Multiple Myeloma PROFAST

What's the purpose of this trial?

This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and smoldering waldenstrom macroglobulinemia (SWM). The purpose of this study is to understand if fasting for a prolonged period of time during the nighttime hours is a strategy to prevent overweight and obese individuals from developing blood cancer.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • BMI >= 25 kg/m2
  • Documented diagnosis of MGUS or Smoldering MM(SMM) or Smoldering Waldenstrom Macroglobulinemia(WM) via EMR review. *note: please review case with PI or treating MD if diagnosis is uncertain.
  • At least 18 years of age
  • Currently fasting for <14 hours per night, as assessed using 24-hour food recalls
  • Owns a cell phone and is comfortable sending and receiving text messages
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Diagnosis of overt MM or WM
  • Patients diagnosed with another malignancy requiring active therapy
  • Clinical diagnosis of diabetes, which may increase the risk of hypoglycemia with a prolonged fast. Note: patients with diabetes may enroll with consent from MD that manages their clinical care.
  • Any other condition that, in the investigator's judgment, would contraindicate prolonged nightly fasting or otherwise interfere with participation in the trial, including night shift work, night eating syndrome, taking weight loss medication, or participation in another weight loss program

Additional Trial Information

Observational Trial

Enrollment: 40 patients (estimated)

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Trial Locations

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Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting
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