A Decentralized Randomized Dietary Trial in Newly Diagnosed Multiple Myeloma - NUTRIVENTION5
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 w…
Interventions
- Othernutrition 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.
- Otherdietary 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
- BehavioralQuestionnaires
Block FFQ survey, EORTC QLQ C30 survey, EORTC MY20 survey, Pre intervention survey, Post intervention survey
- OtherFrozen 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.
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York