Nutrivention Trials | Urvi Shah, MD | ASH 2022

Hi, everyone. I'm Urvi Shah from Memorial Sloan Kettering Cancer Center on the Myeloma Service. I'd like to discuss updates on the neutro-revention trials with you. What's exciting is from our pilot neutro-revention trial, we now have actually, all patients on the study have finished three months on the intervention and the last patient received their meals and finished that earlier this end of November. Since we've completed the intervention part for all patients, we're now going to start analyzing some of these samples for further correlatives or understanding biomarkers around it. What we did already is some of the patients that had finished, we had analyzed some of these samples a few months ago and we presented those results at the meeting. What we did show was that patients had a median reduction in their BMI on the study. Remember, these were patients who had a BMI over 25 when they began the study and they saw a median BMI reduction of 8% over three months. We also saw an adherence of unprocessed plant food intake before the study of 19% and then during the study 12 weeks, it went up to 91%. So patients were really able to follow this as well. We then looked at things like hemoglobin A1C, which is a marker of diabetes, LDL cholesterol, and also insulin, IGF-1, adiponectin leptin ratio, all markers of insulin resistance, and we saw an improvement in all of these markers. We also looked at short chain fatty acids in the stool. These are metabolites made by bacteria and we saw an increase in the butrate levels in the stool and a decrease in branch chain fatty acids in the stool as well. We looked at some inflammatory markers as well and saw a decrease in the CRP or C-reactive protein. With all of this information, this gives us evidence of feasibility and acceptability for patients in terms of adherence, weight reduction, and some biomarkers that are associated with cancer risk. I think more to come in terms of long-term follow-up and how patients are able to follow this beyond the three months of the intervention. The next study I wanted to talk to you about is the Nutrivention 3 study. The Nutrivention 3 study is expanding on this pilot study and it has actually, happy to share that it has finally started to enroll at Memorial Sloan Kettering. It's also going to open at Emory in a few months, I would assume sometime early next year. This study is a 150-patient study, MGUS and small ring myeloma with any BMI. Patients get randomized to either diet or supplements, which is curcumin and omega-3 or placebo supplements, but those on the supplement arms also get the diet just three months later. So everybody gets the meals on the study, it's just at what time point they get it. In this study we will be collecting samples like stool, blood, bone marrow, and imaging tests just to make sure that a patient hasn't progressed. And with all of that information we will be able to study more in depth than the pilot study where we only had 20 patients. So if anybody is interested in this study, please feel free to reach out and you would need to come to Memorial Sloan Kettering or Emory once it opens in total about six times in one year, calendar year, it's spread out over the year. So as long as you're able to travel to New York or one of our satellite locations, we would be happy to have you on the study. And feel free to reach out if you'd like to discuss this further. We also have one more study, the Neutravention IV study, and this is in a different setting, this is in the survivorship setting. So this is patients who have finished chemotherapy after a myeloma diagnosis and they're now on considering maintenance therapy. In this study we looked at daratumumab versus lenalidomide as maintenance options. It's a randomized study and we're looking at quality of life, whether it's different on lenalidomide compared to daratumumab. This study has been enrolling at Memorial Sloan Kettering Cancer Center too and that's something we'd again be happy to have you if you're at the time where you're within the first six months of finishing your chemotherapy or plus minus transplant and had a very good partial response or better. While the patients are on the study, at year one or year two on the study, we have the option for the first 15 patients on each arm to get a dietary intervention of three months where we would ship you meals to understand the effect of diet with the immune system on the microbiome and long-term and MRD negativity rates. So with that I'll conclude and the last study that you are aware about is the Neutravention II study with the Health Tree Foundation that we're working on. That study is going to open probably early next year and we're still working out the kinks and getting it together and I'm really excited for that because that will be a national telemed randomized study and you could pretty much be anywhere in the country and take part for all smoldering myeloma patients. Thank you.