A Dietary Study for People With Multiple Myeloma (NCT07226609) | Clinical Trial Compass
RecruitingNot Applicable
A Dietary Study for People With Multiple Myeloma
United States220 participantsStarted 2025-11-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 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 a…