Actively Recruiting
A Dietary Study for People With Multiple Myeloma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-05
220
Participants Needed
7
Research Sites
156 weeks
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
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
Official Title
A Dietary Study for People With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed multiple myeloma
- Pathological confirmation by bone marrow biopsy with cytogenetics (FISH, SNP array, or genomic sequencing) and blood myeloma marker evaluation
- Age 18 years or older
- Bone marrow involvement
- Planned for four 28-day cycles of daratumumab (or isatuximab), lenalidomide, bortezomib, dexamethasone (DRVd) induction chemotherapy
- All 4 planned drugs started by cycle 2 day 1
- Enrollment before cycle 1 day 21 of induction chemotherapy
- Treatment at a site able to perform bone marrow MRD negativity testing at end of 4 cycles
- Treatment at MSK or site with EPIC electronic medical records and data sharing capability
- Prior dexamethasone treatment allowed
- Up to one cycle of cyclophosphamide and/or bortezomib with dexamethasone 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 while on trial
- Participant or caregiver able to complete surveys
- Baseline diet includes less than 30 grams of dietary fiber per day
- Not following a minimally processed whole food plant-based diet in last 3 months (ovo-lacto-vegetarian or processed vegan diets allowed)
You will not qualify if you...
- Leptomeningeal or central nervous system involvement
- Prior combination cytotoxic infusion chemotherapy such as VDPACE or DCEP
- Body mass index less than 19 kg/m2
- Any investigator concerns about safety or contraindications
- Severe allergy to any legume or risk of cross-contamination
- Severe allergies causing anaphylactic shock to peanuts or tree nuts such as cashews
- Enrollment in concurrent therapeutic studies requiring treatment other than 4 cycles of DRVd
- Participation in concurrent weight loss or dietary programs requiring specific diets or supplements
- Planned prolonged travel preventing adherence to prescribed diet
AI-Screening
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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
CONTACT
C
Carlyn Rose Tan, MD
CONTACT
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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