A Dietary Study for People With Multiple Myeloma

A Decentralized Randomized Dietary Trial in Newly Diagnosed Multiple Myeloma - NUTRIVENTION5

The purpose of the study is to find out whether a dietary intervention can affect treatment response and/or quality of life for people with newly diagnosed multiple myeloma receiving standard induction chemotherapy with daratumumab (or isatuximab), lenalidomide, bortezomib, and dexamethasone (DRVd). The researchers will measure quality of life by having participants complete questionnaires. The study will investigate the effects of diet on quality of life, treatment response, and other disease, microbiome, and immune markers.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Behavioral: Questionnaires; Other: dietary guidelines, research dietitian visit; Other: nutrition counseling and coaching; Other: Frozen pre-prepared meals

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlyn Rose Tan, MD; Phone Number: 646-608-3778
• Study Contact Backup: Name: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited protocol activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Carlyn Rose Tan, MD; Phone Number: 646-608-3778
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Urvi A Shah, MD, MS; Phone Number: 646-608-3713; Email: ShahNutrivention@mskcc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newly diagnosed multiple myeloma
• Patients must have pathologically confirmed multiple myeloma on bone marrow biopsy with cytogenetics via Florescence in Situ Hybridization (FISH) or SNP array or genomic sequencing report and evaluation of blood myeloma markers (quantitative immunoglobulins, free light chains, serum protein electrophoresis and immunofixation).
• Age ≥ 18 years
• Bone marrow involvement
• Planned for four 28-day cycles of daratumumab (or isatuximab), lenalidomide, bortezomib, dexamethasone (or any other steroid) (DRVd) induction chemotherapy (with once weekly bortezomib day 1, 8, 15 and lenalidomide 21/28 days).
• All 4 planned drugs initiated by C2D1.
• Must enroll before C1D21 of induction chemotherapy as study intervention starts at C2D1.
• Treatment at a site where treating oncologist has capability and plan to send for bone marrow MRD negativity by next generation sequencing at end of 4 cycles (EOI). To be confirmed with local oncologist at enrollment.
• Treatment at MSK or at a site that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's Care Everywhere or through MSK's shared care network.
• Enrollment on another trial that allows for 4 cycles of 28-day DRVd is acceptable.
• Prior dexamethasone treatment is eligible.
• Patients who have received up to one cycle of cyclophosphamide and/or bortezomib with dexamethasone for disease control are eligible.
• Able to complete study procedures and visits.
• Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to C2D1 DRVd or if it has been started more recently for diabetes mellitus control but not weight loss. If it is medically indicated and started for diabetes mellitus control while on trial they will not be removed/excluded from trial.
• 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.
• Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).

Exclusion Criteria:

• Leptomeningeal/CNS involvement
• Prior cycles of combination cytotoxic infusion chemotherapy such as VDPACE or DCEP are not eligible.
• Patients with BMI ≤19 kg/m2 are excluded.
• If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.
• Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.
• Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews are not eligible.
• Enrollment onto concurrent therapeutic study that requires patient receives treatment other than 4 cycles of DRVd induction as described above.
• Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.
• Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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.	Behavioral: Questionnaires; Block FFQ survey, EORTC QLQ C30 survey, EORTC MY20 survey, Pre intervention survey, Post intervention survey; Other: nutrition counseling and coaching; In addition to individual counseling, patients will be able to join optional group sessions every 2 weeks as well as text message check-ins for survey completion reminders. Patients will receive 12 frozen, fixed pre-made lunch and dinner shipped to their home weekly from Modify Health for 12 weeks.; Other: Frozen pre-prepared meals; Patients will receive 12 frozen, fixed pre-made lunch and dinner shipped to their home weekly from Modify Health for 12 weeks.
Active Comparator: Usual care (UC); 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.	Behavioral: Questionnaires; Block FFQ survey, EORTC QLQ C30 survey, EORTC MY20 survey, Pre intervention survey, Post intervention survey; Other: dietary guidelines, research dietitian visit; Participants will have phone calls with a member of the study team every 4 weeks as well as text message check-ins for survey completion reminders. At the end of standard induction chemotherapy, participants will have a phone call or video call with a dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal residual disease negative complete response (MRD-CR) rate	rates by IMWG criteria	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the rates of improvement in QOL	global health status per EORTC QLQ C30 survey administration	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Blood Cancer United
• Investigators: Principal Investigator: Urvi A Shah, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 7, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dietary Trial; Dietary Risk Factors; High fiber plant-based diet; 25-237
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Care Economics and Organizations; Health Policy; Public Policy; Social Control Policies; Policy; Surveys and Questionnaires; Nutrition Policy
• Other Study ID Numbers: 25-237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No