NCT07226609

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
29mo left

Started Nov 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Nov 2025Nov 2028

First Submitted

Initial submission to the registry

November 4, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

November 4, 2025

Last Update Submit

May 4, 2026

Conditions

Multiple Myeloma

Keywords

Dietary TrialDietary Risk FactorsHigh fiber plant-based diet25-237

Outcome Measures

Primary Outcomes (1)

  • Minimal residual disease negative complete response (MRD-CR) rate

    rates by IMWG criteria

    1 year

Secondary Outcomes (1)

  • compare the rates of improvement in QOL

    1 year

Study Arms (2)

Usual care (UC)

ACTIVE COMPARATOR

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.

Other: dietary guidelines, research dietitian visitBehavioral: Questionnaires

Intervention arm

EXPERIMENTAL

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.

Other: nutrition counseling and coachingBehavioral: QuestionnairesOther: Frozen pre-prepared meals

Interventions

dietary guidelines, research dietitian visitOTHER

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

Usual care (UC)
QuestionnairesBEHAVIORAL

Block FFQ survey, EORTC QLQ C30 survey, EORTC MY20 survey, Pre intervention survey, Post intervention survey

Intervention armUsual care (UC)
Frozen pre-prepared mealsOTHER

Patients will receive 12 frozen, fixed pre-made lunch and dinner shipped to their home weekly from Modify Health for 12 weeks.

Intervention arm
nutrition counseling and coachingOTHER

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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Nutrition PolicySurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Health PolicyPublic PolicySocial Control PoliciesPolicyHealth Care Economics and OrganizationsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Urvi A Shah, MD, MS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Urvi A Shah, MD, MS

CONTACT

646-608-3713ShahNutrivention@mskcc.org

Carlyn Rose Tan, MD

CONTACT

646-608-3778

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a nontherapeutic study testing a high fiber plant based dietary intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2025

First Posted

November 10, 2025

Study Start

November 4, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)