A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM) NUTRIVENTION

What's the purpose of this trial?

This study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. The researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. In addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants' quality of life.

This trial is currently open and accepting patients.

What will happen during the trial?

Patients will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.

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
  • Confirmed diagnosis of MGUS or SMM
  • M spike (immunoglobulin) ≥0.2 g/dL or abnormal free light chain ratio with increased level of the appropriate involved light chain
  • Secretory disease
  • Age ≥18 years
  • Willingness to comply with all study-related procedures
  • ECOG performance status of 0-3
  • Interest to learn to cook plant based recipes

Exclusion Criteria:

  • Patients that already follow a whole foods plant based or vegan diet (ovo-lactovegetarian diets are not excluded)
  • Legume allergy
  • Severe allergies, such as anaphylactic shock to peanuts
  • Concurrent participation in weight loss/dietary/exercise programs
  • Mental impairment leading to inability to cooperate
  • Enrollment onto any other therapeutic investigational study
  • Concurrent pregnancy
  • Patients with a known diagnosis of diabetes mellitus will not be excluded but will need to be followed regularly with an endocrinologist/primary care physician during the trial period.
  • Positive HBV, HCV, HIV PCR testing
  • Non English speaking
  • ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
  • If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely

Additional Trial Information

Pilot Trial

Enrollment: 20 patients (estimated)

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Published Results

Plantable Health Announces Preliminary Results from Its Myeloma Cancer Trial

October 04, 2022

The Myeloma Cancer Trial led by Urvi A. Shah, M.D., a Hematologist/Oncologist and Physician Scientist at Memorial Sloan Kettering Cancer Center (MSK), sets out to study the feasibility of the Plantable intervention in overweight and obese patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) and its impact on disease markers.

Preliminary Interim Results at 12 weeks

Metabolic markers showed improvement across all studied markers:

  • BMI median 7% reduction (with weight loss > 5% being considered clinically meaningful)
  • Reduction in LDL
  • Reduction in blood sugar (HgbA1c), insulin and insulin-like growth factor-1.
  • Reduction in inflammatory markers
  • Positive improvement in the microbiome

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

New Jersey

Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

Commack, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center Westchester in West Harrison

West Harrison, NY

Open and Accepting

Trial Links

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