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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04920084
Other study ID # 21-135
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 3, 2021
Est. completion date June 2025

Study information

Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 23
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Plant based meals
For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks.

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss- body mass index (BMI) reduction Weight loss is defined as the average decrease in BMI at 12 weeks 12 weeks
Primary Patient adherence to the diet Intervention defined as =70% of participants consuming a WFPBD for =70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey). 12 weeks
See also
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Active, not recruiting NCT02916771 - Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma Phase 2
Completed NCT01955395 - Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma N/A
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Completed NCT00099047 - Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma Phase 2
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Active, not recruiting NCT02886065 - A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM Phase 1