Dietary Guidelines for Multiple Myeloma

Recruiting at 6 trial locations

Overseen By Urvi Shah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Daratumumab, Lenalidomide, Bortezomib, Dexamethasone

Disqualifiers: CNS involvement, Low BMI, Severe allergies, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-fiber, plant-based diet can enhance the treatment response or quality of life for people with multiple myeloma undergoing standard chemotherapy. Participants will follow this diet while receiving their usual cancer treatment, and researchers will assess any improvement in quality of life through questionnaires. This trial suits individuals newly diagnosed with multiple myeloma who are about to start chemotherapy and currently consume less than 30 grams of fiber daily. As an unphased trial, it offers a unique opportunity to explore potential dietary benefits alongside standard treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients on certain diabetes medications (GLP-1 drugs) can participate if they meet specific conditions. It's best to discuss your current medications with the trial team to get a clear answer.

What prior data suggests that this high-fiber plant-based diet is safe for people with multiple myeloma?

Research has shown that a high-fiber plant-based diet is generally safe for most people. One study found that participants found this diet easy to follow and it improved their overall diet quality. Over 12 weeks, participants did not experience any major negative side effects.

Another study suggested that this type of diet might help slow the progression of multiple myeloma, a kind of blood cancer. The diet, which mainly includes beans, fruits, and vegetables, is linked to a lower risk of this cancer.

In summary, a high-fiber plant-based diet appears safe and may offer health benefits for those at risk of or living with multiple myeloma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring a high-fiber plant-based diet for multiple myeloma patients because it offers a novel approach to supporting standard chemotherapy. Unlike traditional treatments focused solely on medication, this diet aims to enhance overall health and potentially improve treatment outcomes by introducing a dietary strategy that emphasizes high fiber and plant-based nutrients. The frequent interaction with dietitians ensures personalized guidance and support, making it a proactive addition to conventional care. This approach could lead to improved patient well-being and possibly better chemotherapy tolerance.

What evidence suggests that a high-fiber plant-based diet might be effective for improving treatment response or quality of life in multiple myeloma?

Research has shown that a high-fiber, plant-based diet might benefit people with multiple myeloma, a type of blood cancer. In this trial, participants in the intervention arm will receive high-fiber plant-based meals for 12 weeks while undergoing standard induction chemotherapy. Studies have found that this diet can potentially slow the disease and improve survival rates. One study found that participants who followed the diet adhered well and improved their eating habits over 12 weeks. Another study suggested that this kind of diet might reduce the risk of developing multiple myeloma. These findings indicate that consuming more fiber-rich plant foods could support better health for people with this condition. ^{1 2 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 individuals with multiple myeloma who are undergoing standard chemotherapy treatment. Participants will be asked to follow a high-fiber plant-based diet and attend nutrition counseling sessions.

Inclusion Criteria

Able to complete study procedures and visits

Participant or caregiver must be able to complete surveys

Baseline 24-hour dietary recall must consume <30 grams dietary fiber per day to be eligible

Exclusion Criteria

Patients with BMI ≤19 kg/m2 are excluded

If in the opinion of the investigator there may be any concerns regarding the ability of the patient to complete the study safely or any contraindications

Enrollment onto concurrent therapeutic study that requires patient receives treatment other than 4 cycles of DRVd induction as described above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard induction chemotherapy with daratumumab (or isatuximab), lenalidomide, bortezomib, and dexamethasone (DRVd) while following a high-fiber plant-based diet

12 weeks

Phone or video calls every 2 weeks with a dietitian

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

1 year

What Are the Treatments Tested in This Trial?

Interventions

• High-fiber Plant-based Diet

Trial Overview The study tests if a high-fiber plant-based diet can boost the effectiveness of standard chemotherapy or improve quality of life in multiple myeloma patients, using questionnaires to measure outcomes.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 3 Interventions

While receiving standard induction chemotherapy as part of routine care,participants will have a phone call or video call with a dietitian every 2 weeks for 12 weeks and will receive high-fiber plant-based meals for 12 weeks.

Group II: Usual care (UC) Active Control 2 Interventions

Usual care (UC) While receiving standard induction chemotherapy as part of routine care, participants will have phone calls with a member of the study team every 4 weeks. At the end of standard induction chemotherapy, participants will have a phone call or video call with a dietitian.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Blood Cancer United

Collaborator

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

Citations

1. mskcc.org mskcc.org/news-releases/new-study-reveals-fiber-diet-may-delay-type-of-blood-cancer

New Study Reveals a Fiber Diet May Delay a Type of ... A high fiber plant based dietary intervention may delay progression to multiple myeloma, a type of rare, incurable blood cancer affecting the bone marrow.

2. bloodcancerunited.org bloodcancerunited.org/research/decentralized-randomized-high-fiber-dietary-trial-improve-outcomes-newly-diagnosed-myeloma

A Decentralized Randomized High-Fiber Dietary Trial to ... Our prior research in MM suggests that plant forward diets are associated with reduced MM risk and improved survival outcomes, as well as a ...

3. ascopost.com ascopost.com/news/december-2024/high-fiber-diet-may-slow-disease-progression-to-multiple-myeloma/

High-Fiber Diet May Slow Disease Progression to Multiple ... The median overall adherence to the high-fiber, plant-based diet was 91% during the first 3 months and 58% at the end of the year, ...

4. hematologyadvisor.com hematologyadvisor.com/news/high-fiber-plant-based-diet-may-be-beneficial-for-monoclonal-gammopathy-multiple-myeloma/

High-Fiber Plant-Based Diet May Be Beneficial for ... From baseline to week 12, there was an increase in median dietary adherence from 20 to 91 percent, while median BMI decreased (−6.6 percent).

5. 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.

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. healio.com healio.com/news/primary-care/20250602/qa-highfiber-plantbased-diet-may-lower-multiple-myeloma-risk

Q&A: High-fiber, plant-based diet may lower multiple ... The median BMI of participants at risk for multiple myeloma decreased by nearly 7% after 12 weeks of a high-fiber diet.