Trials / Recruiting
RecruitingNCT07226609
A Dietary Study for People With Multiple Myeloma
A Decentralized Randomized Dietary Trial in Newly Diagnosed Multiple Myeloma - NUTRIVENTION5
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | 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 |
| BEHAVIORAL | Questionnaires | Block FFQ survey, EORTC QLQ C30 survey, EORTC MY20 survey, Pre intervention survey, Post intervention survey |
| 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. |
Timeline
- Start date
- 2025-11-04
- Primary completion
- 2028-11-01
- Completion
- 2028-11-01
- First posted
- 2025-11-10
- Last updated
- 2025-12-30
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT07226609. Inclusion in this directory is not an endorsement.