Plant-Based Diet for Early Stage Multiple Myeloma

Not currently recruiting at 6 trial locations

Overseen By Alexander Lesokhin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Vegan diet, Legume allergy, Severe allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a plant-based diet can aid individuals who are overweight and have early-stage blood conditions like MGUS or SMM, which could progress to multiple myeloma, a type of cancer. The study will assess participants' adherence to the diet, its impact on weight loss, and its effects on overall quality of life. Additionally, it aims to determine if this diet can prevent the condition from worsening. Suitable candidates include those with a confirmed diagnosis of MGUS or SMM, a BMI of 25 or higher, and an interest in learning plant-based cooking. As an unphased trial, this study presents a unique opportunity to investigate lifestyle changes that could enhance health and prevent disease progression.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this plant-based diet is safe for participants?

Research has shown that a plant-based diet might be a safe choice for people at risk of developing multiple myeloma. Studies have found that consuming plant-based foods, such as beans, fruits, and vegetables, which are high in fiber, is linked to a lower risk of this condition. Thus, individuals who eat these foods may be less likely to develop multiple myeloma.

Additionally, past trials have suggested that a high-fiber plant-based diet could be beneficial for those at risk, supporting its safety and potential advantages. No evidence indicates serious harm from following a plant-based diet, making it a well-tolerated option for many.

Overall, the available research supports the safety of plant-based diets for people with early-stage conditions related to multiple myeloma, making it a promising choice for those seeking to manage their health through diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for early stage multiple myeloma, which often involve chemotherapy, steroids, or immunotherapy, this new approach features a whole-foods plant-based diet. Researchers are excited because this diet emphasizes natural, nutrient-rich ingredients that could improve overall health without the side effects typically associated with drug therapies. Additionally, the inclusion of nutrition counseling offers personalized support, potentially enhancing adherence and effectiveness. This innovative approach might provide a gentler, more holistic way to manage the condition and improve patients' quality of life.

What evidence suggests that a plant-based diet is effective for early stage multiple myeloma?

Research suggests that a plant-based diet might slow the progression of conditions like MGUS and SMM to multiple myeloma. Studies have shown that people who primarily consume plants tend to have a lower risk of developing multiple myeloma compared to those who eat meat. A diet high in plant fiber might also benefit those at risk for this cancer type. Healthier eating habits, including more fruits, vegetables, and whole foods, have been linked to lower death rates in multiple myeloma patients. This trial will evaluate the effects of a plant-based diet, as participants will follow a whole-foods plant-based diet for 12 weeks, with nutrition counseling for 24 weeks. Increasing plant-based meals could be a promising way to manage these conditions. ^{2 3 5 6 7}

Who Is on the Research Team?

Urvi A Shah, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for overweight adults with MGUS or SMM who have a BMI of 25 or higher, an M spike ≥0.2 g/dL, and are willing to learn plant-based cooking. Excluded are those with severe allergies, current participation in other studies or dietary programs, certain medical conditions as judged by the investigator, non-English speakers, and those already on vegan diets.

Inclusion Criteria

You have high levels of a specific protein called M spike or abnormal levels of a certain type of light chain in your blood.

I have been diagnosed with MGUS or SMM.

I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

You are currently part of a weight loss, diet, or exercise program.

I am mentally capable of following study procedures.

You have severe allergies, like a serious reaction to peanuts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a whole-foods plant-based diet with nutrition counselling

12 weeks

Regular virtual check-ins via MSK Engage

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plant based meals

Trial Overview

The study is testing the feasibility and effectiveness of a plant-based diet in preventing multiple myeloma among participants with MGUS or SMM. It will measure weight loss adherence to the diet's practicality and its impact on quality of life.

How Is the Trial Designed?

Group I: Plant-based meals Experimental Treatment 1 Intervention

Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 61 patients with multiple myeloma, those with low carbohydrate intake showed significant improvements in clinical parameters like hemoglobin and albumin compared to those with medium carbohydrate intake, suggesting that diet quality may influence disease outcomes.

Despite the observed effects of diet on clinical parameters, patients' nutrition knowledge did not correlate with their clinical status or nutrient intake, indicating a need for better nutritional education and personalized dietary advice for improving patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Carbohydrate Diet Is Associated with Severe Clinical Indicators, but Not with Nutrition Knowledge Score in Patients with Multiple Myeloma. Borsi, E., Serban, CL., Potre, C., et al.[2021]

In a study of 5,764 participants, consuming fruit at least three times a week during adolescence was linked to a lower risk of developing monoclonal gammopathy of undetermined significance (MGUS), with an odds ratio of 0.62.

Additionally, higher fruit intake in late life was associated with a significantly reduced risk of progression from MGUS to multiple myeloma (MM), with a hazard ratio of 0.34, suggesting that diet may play a role in both the development and progression of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake is associated with risk of multiple myeloma and its precursor disease. Thordardottir, M., Lindqvist, EK., Lund, SH., et al.[2019]

A study of 423 multiple myeloma patients showed that healthier dietary patterns, such as those reflected in the Alternate Healthy Eating Index, are associated with a 15-24% lower risk of MM-specific mortality, suggesting that diet may influence survival outcomes.

Conversely, patients with less healthy dietary habits, indicated by higher scores in the Western dietary pattern, experienced a 16-24% increase in MM-specific mortality, highlighting the potential impact of diet on disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediagnosis dietary pattern and survival in patients with multiple myeloma. Lee, DH., Fung, TT., Tabung, FK., et al.[2022]

In the NIH-AARP Diet and Health study, which included 392,589 participants and identified 1,366 cases of multiple myeloma (MM), a healthful plant-based diet was associated with a reduced risk of developing MM, suggesting dietary choices may influence cancer risk.

While the association between a healthful plant-based diet and reduced MM risk was significant, it became less clear in sensitivity analyses, indicating that further research is needed to confirm these findings, especially since MM is a rare disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Diagnosis Dietary Patterns and Risk of Multiple Myeloma in the NIH-AARP Diet and Health Study. Castro, F., Parikh, R., Eustaquio, JC., et al.[2023]

In a study of 3646 breast cancer survivors over a median follow-up of 9.51 years, a healthful plant-based diet was linked to a lower risk of all-cause and non-breast-cancer mortality, suggesting potential benefits for overall survival.

Conversely, a diet high in unhealthful plant-based foods was associated with an increased risk of mortality, highlighting the importance of focusing on healthful plant foods in dietary recommendations for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-Based Dietary Patterns and Breast Cancer Recurrence and Survival in the Pathways Study. Anyene, IC., Ergas, IJ., Kwan, ML., et al.[2022]

Higher levels of stool butyrate and butyrate-producing bacteria, as well as greater microbiome diversity, were linked to sustained minimal residual disease (MRD) negativity in multiple myeloma patients, suggesting a potential role of gut health in cancer outcomes.

A plant-based diet rich in healthy proteins and flavonoids was associated with increased stool butyrate levels and sustained MRD negativity, indicating that dietary factors may influence treatment effectiveness in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Minimal Residual Disease Negativity in Multiple Myeloma is Associated with Stool Butyrate and Healthier Plant-Based Diets. Shah, UA., Maclachlan, KH., Derkach, A., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06055894

NCT06055894 | A Study of a Plant-Based Diet and Dietary ...

The purpose of this study is to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements ...

2.

mskcc.org

mskcc.org/news/diets-for-mgus-smoldering-myeloma-and-multiple-myeloma-q-with-msk-cancer-and-nutrition-experts

Diets for MGUS, Smoldering Myeloma, and Multiple Myeloma

“This is the first study of its kind to show that a high-fiber plant-based intervention may delay progression from MGUS or SMM to multiple ...

3.

withpower.com

withpower.com/trial/phase-paraproteinemias-5-2021-6b3fc

Plant-Based Diet for Early Stage Multiple Myeloma

Research suggests that healthier dietary patterns, which can include plant-based meals, are associated with lower mortality in multiple myeloma patients.

4.

news-medical.net

news-medical.net/news/20250602/High-fiber-plant-based-diet-could-benefit-patients-at-risk-for-developing-multiple-myeloma.aspx

High-fiber plant-based diet could benefit patients at risk for ...

Results from a new clinical trial suggest that a high-fiber plant-based diet could benefit patients at risk for developing multiple myeloma.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10443185/

Dietary and microbiome evidence in multiple myeloma ...

MM risk was lower in those with plant-based dietary patterns when compared with meat-eaters. Consumption of fruits, vegetables especially ...

6.

bloodcancerstoday.com

bloodcancerstoday.com/post/study-identifies-dietary-risk-factors-for-myeloma

Plant-Based Diet Associated With Reduced Myeloma Risk

A plant-based diet of beans, fruits, and vegetables is significantly associated with a reduced risk of multiple myeloma, attributed to an ...

7.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/671/530290/A-High-Fiber-Dietary-Intervention-NUTRIVENTION-in

A High-Fiber Dietary Intervention (NUTRIVENTION) in ...

Plant-based diets have been associated with reduced risk of MGUS and MM in epidemiological studies. Whether a dietary intervention can impact ...