Actively Recruiting
A Decentralized Randomized Dietary Trial in Newly Diagnosed Multiple Myeloma - NUTRIVENTION5
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-05
220
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
B
Blood Cancer United
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a dietary intervention can influence treatment response and quality of life in people with newly diagnosed multiple myeloma undergoing standard induction chemotherapy with daratumumab (or isatuximab), lenalidomide, bortezomib, and dexamethasone (DRVd). The study aims to assess the effects of diet on quality of life, treatment response, and various disease, microbiome, and immune markers by having participants complete questionnaires and other evaluations. Participants are randomly assigned to one of two groups. One group receives usual care, which includes standard chemotherapy and phone calls every 4 weeks with study staff and a dietitian consultation at the end of chemotherapy. The other group receives an intervention with nutrition counseling and coaching, including biweekly dietitian calls for 12 weeks and high-fiber plant-based frozen meals shipped weekly for 12 weeks. Optional group sessions and text message reminders are also provided. Both groups complete dietary and quality of life surveys during the study. During the study, participants complete questionnaires measuring quality of life and dietary intake. Researchers will evaluate the rate of minimal residual disease negative complete response at one year and compare quality of life improvements between groups. Phone or video calls with dietitians and study staff support participant engagement. The study lasts through four 28-day chemotherapy cycles with follow-up assessments up to one year to monitor treatment and quality of life outcomes.
CONDITIONS
Brief Title
A Dietary Study for People With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed multiple myeloma
- Pathologically confirmed multiple myeloma on bone marrow biopsy with cytogenetic or genomic evaluation
- Age 18 years or older
- Bone marrow involvement
- Planned for four 28-day cycles of daratumumab (or isatuximab), lenalidomide, bortezomib, dexamethasone induction chemotherapy
- All four planned drugs started by cycle 2 day 1
- Enrollment before cycle 1 day 21 of induction chemotherapy
- Treatment at a site capable of bone marrow MRD testing by next generation sequencing after 4 cycles
- Treatment at MSK or site using EPIC electronic medical records willing to share records
- Enrollment on another trial allowing these 4 cycles is acceptable
- Prior dexamethasone treatment is allowed
- Up to one cycle of cyclophosphamide and/or bortezomib with dexamethasone for disease control allowed
- Able to complete study procedures and visits
- On GLP-1 drugs started at least 3 months before cycle 2 day 1 or for diabetes control during trial
- Participant or caregiver can complete surveys
- Baseline dietary fiber intake less than 30 grams per day
- Not following a minimally processed whole food plant-based diet in last 3 months
You will not qualify if you...
- Leptomeningeal or central nervous system involvement
- Prior cycles of combination cytotoxic chemotherapy like VDPACE or DCEP
- Body mass index less than 19 kg/m2
- Investigator concerns about ability to safely complete study
- Severe allergy to any legume causing anaphylactic shock or multiple legume allergies with cross-contamination risk
- Severe allergy to peanuts or tree nuts such as cashews causing anaphylactic shock
- Enrollment in concurrent therapeutic trial requiring treatment other than 4 cycles of DRVd induction
- Concurrent weight loss or dietary programs requiring specific diets or supplements
- Planned prolonged travel that would prevent adherence to prescribed diet (unless willing to comply during travel)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 12 weeks
Participants receive standard induction chemotherapy as part of routine care while following assigned dietary interventions including nutrition counseling, coaching, and receiving pre-made meals or dietary guidelines with dietitian support.
Phone or video calls every 2 to 4 weeks; optional group sessions every 2 weeks; weekly meal deliveries
Duration - Up to 1 year
Participants have a phone or video call with a dietitian at the end of the induction chemotherapy to assess dietary adherence and health status.
1 phone or video call
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
U
Urvi A Shah, MD, MS
C
Carlyn Rose Tan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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