What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma include chemotherapy, immunotherapy, corticosteroids, and supportive treatments like plant-based diets, omega-3 fatty acids, and curcumin supplements. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, and increased risk of infections. Immunotherapy may lead to fatigue, fever, and infusion reactions. Corticosteroids can result in weight gain, high blood sugar, and increased susceptibility to infections. Plant-based diets are generally well-tolerated but may cause gastrointestinal changes. Omega-3 fatty acids can lead to gastrointestinal upset and a fishy aftertaste, while curcumin supplements are usually safe but may cause mild digestive issues.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including proteasome inhibitors (e.g., bortezomib, carfilzomib), immunomodulatory drugs (e.g., lenalidomide, pomalidomide), and monoclonal antibodies (e.g., daratumumab, elotuzumab). While these treatments are not directly related to dietary interventions, they aim to target the cancer cells and modulate the immune system. The trial studying a plant-based diet, omega-3 fatty acids, and curcumin supplements is unique in its approach to potentially altering gut microbiota and increasing butyrate production, which may have anti-inflammatory and anti-cancer effects. This represents a novel area of research distinct from traditional pharmacological treatments.

What other types of research exist?

Promising alternatives to a plant-based diet for Multiple Myeloma patients include omega-3 fatty acid supplements, curcumin supplements, and potentially other dietary interventions that focus on increasing fiber intake or incorporating whole grains. These alternatives aim to alter gut microbiota and increase butyrate production, which may have beneficial effects for Multiple Myeloma patients.

← Back to Search

Behavioural Intervention

Plant-Based Diet With Supplements for Multiple Myeloma

N/A

Recruiting

Led By Urvi Shah, MBBS

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Confirmed diagnosis of MGUS or SMM

Must not have

Mental impairment leading to inability to cooperate

Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial is testing how a plant-based diet, fish oil supplements, and turmeric supplements affect butyrate levels in the stool. The study involves people with specific blood conditions called MGUS or SMM. Researchers want to see if these dietary changes and supplements can increase butyrate, a substance in the gut that can influence health. Fish oil supplements have been shown to lower plasma triglyceride levels but may increase LDL cholesterol and apolipoprotein B levels.

Who is the study for?

Adults diagnosed with MGUS or SMM who are interested in a plant-based diet and willing to follow study procedures can join. They must have specific blood protein levels based on their condition type, be able to cook plant-based recipes, and not already be on such a diet. Exclusions include drug use, other clinical trials participation, severe food allergies, heavy alcohol consumption, certain infections needing treatment first.

What is being tested?

The trial is testing the effects of a whole foods plant-based diet supplemented with omega-3 from algae and curcumin versus placebo supplements on butyrate levels in stool over at least 12 weeks for those with MGUS or SMM.

What are the potential side effects?

Potential side effects may include digestive changes due to dietary adjustments. Allergies could occur if participants react to any ingredients in the supplements or new foods introduced through the plant-based diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with MGUS or SMM.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am mentally capable of cooperating with treatment.

Select...

I have treated my HBV, HCV, or HIV and now have an undetectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stool microbiome diversity at 12 weeks

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SupplementsExperimental Treatment1 Intervention

For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.

Group II: Daily Harvest weeklyExperimental Treatment1 Intervention

For 12 weeks, on the Daily Harvest weekly arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based company Daily Harvest weekly.

Group III: PlaceboPlacebo Group1 Intervention

For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments primarily include chemotherapy, immunotherapy, targeted therapy, and stem cell transplantation. Chemotherapy works by killing rapidly dividing cancer cells, while immunotherapy boosts the body's immune system to better recognize and destroy myeloma cells. Targeted therapies, such as proteasome inhibitors and monoclonal antibodies, specifically target and disrupt cancer cell functions and signaling pathways. Stem cell transplantation replaces damaged bone marrow with healthy cells. These treatments are crucial for MM patients as they aim to reduce the burden of cancer cells, improve survival rates, and enhance quality of life. The study on plant-based diets altering gut microbiota to increase butyrate production is relevant as it explores non-traditional methods to potentially support gut health and overall well-being in MM patients, which could complement existing treatments.

Effects of Dietary Interventions on Gut Microbiota in Humans and the Possible Impacts of Foods on Patients' Responses to Cancer Immunotherapy.Chemotherapy-driven dysbiosis in the intestinal microbiome.