A Decentralized Randomized High-Fiber Dietary Trial to Improve Outcomes in Newly Diagnosed Myeloma
Urvi Shah
MDMemorial Sloan Kettering Cancer Center
Project Term: March 1, 2025 - February 29, 2028
We will conduct a decentralized randomized controlled trial of a high-fiber plant-based dietary intervention among patients with multiple myeloma undergoing induction chemoimmunotherapy. The study will assess whether the intervention (meals and virtual coaching) leads to improved rates of complete response, and quality of life mediated by improvements in weight and insulin resistance. The study is expected to provide rigorous evidence of the effectiveness of this intervention in patients with newly diagnosed multiple myeloma and support the development of low-cost, minimal-risk nutrition as a strategy to improve cancer treatment outcomes.
Evidence-based dietary guidance to improve outcomes is a priority for patients with cancer, including those with multiple myeloma (MM) based on our prior research survey, yet research in this area is extremely limited. To address this unmet need for further research, we will conduct a randomized dietary intervention trial with patients with MM. Our NUTRIVENTION trial was the first to test a high-fiber, plant-based diet (HFPBD) intervention for MM precursor conditions. In this trial, a HFPBD was safe and feasible, improved quality of life (QOL), and reduced insulin resistance (IR) at 12 weeks. A subset of patients had slowed disease progression as well.
Our prior research in MM suggests that plant forward diets are associated with reduced MM risk and improved survival outcomes, as well as a higher likelihood of complete response (absence of minimal residual disease [MRD]) to chemotherapy. Mice with MM that received dietary fiber also lived longer. The majority of patients with newly diagnosed MM (NDMM) receiving chemotherapy have an elevated body mass index (BMI). The patients that gain weight during chemotherapy have a shorter time in remission compared to those that lose weight. Patients with diabetes mellitus (DM) also have shorter survival than those without. This is consistent in mice and suggests that insulin resistance leads to worse outcomes and QOL.
We aim to answer the question: Will patients with newly diagnosed multiple myeloma who also eat a high-fiber, plant-based diet respond better to chemotherapy and have a better quality of life due to improvements in their BMI and insulin resistance?
The results of this 3-year study will be directly beneficial to patients as it will identify a new low-risk intervention that improves the chance of feeling better and responding to chemotherapy. If successful, it will set the foundation to do larger confirmatory trials in MM, as well as similar trials in other blood cancers and then can be widely implemented as standard practice.