Plant-Based Diet for Early Stage Multiple Myeloma

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

23 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Plant based meals 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. Additionally, diets rich in fruits, a component of plant-based meals, may reduce the risk of developing multiple myeloma and its precursor condition. ^{1 2 3 4 5}

Is a plant-based diet safe for humans?

Plant-based diets are generally considered safe for humans and have been associated with reduced risks of certain cancers and improved survival rates in some studies. However, the healthfulness of the diet depends on the quality of plant foods consumed, with healthful plant-based diets linked to better outcomes. ^{1 2 3 4 6}

How does a plant-based diet differ from other treatments for early-stage multiple myeloma?

A plant-based diet is unique because it focuses on dietary changes rather than medication, potentially reducing inflammation and supporting gut health, which may influence multiple myeloma outcomes. Unlike traditional treatments, it emphasizes consuming more fruits, vegetables, and plant-based foods to possibly lower disease risk and improve survival. ^{1 2 3 4 7}

What is 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.

Research Team

Urvi A Shah, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Prediagnosis dietary pattern and survival in patients with multiple myeloma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pre-Diagnosis Dietary Patterns and Risk of Multiple Myeloma in the NIH-AARP Diet and Health Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary intake is associated with risk of multiple myeloma and its precursor disease. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Diet and nutrition as risk factors for multiple myeloma among blacks and whites in the United States. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Plant-Based Dietary Patterns and Breast Cancer Recurrence and Survival in the Pathways Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sustained Minimal Residual Disease Negativity in Multiple Myeloma is Associated with Stool Butyrate and Healthier Plant-Based Diets. [2023]