{"preliminary_commentary":{"by_channel":{"x_thread":2,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NUTRIVENTION-4","nct_id":"NCT04497961","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nutrivention-4-nct04497961. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Arm A: Those randomized to lenalidomide maintenance will receive a maintenance dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up.\n\nSub ARM A: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals provided by Daily Harvest and nutrition counseling for 12 weeks. They will continue on their lenalidomide maintenance schedule per study calendar.\n\nThe patients who do not go on the nutrition sub study will continue on their lenalidomide maintenance schedule per study calendar.","label":"Lenalidomide maintenance","type":"EXPERIMENTAL"},{"description":"ARM B: Those randomized to receive daratumumab maintenance will receive 1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up.\n\nSub ARM B: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals provided by Daily Harvest and nutrition counseling for 12 weeks. They will continue on their daratumumab maintenance schedule per study calendar.\n\nThe patients who do not go on the nutrition sub study will continue on their daratumumab maintenance schedule per study calendar.","label":"Daratumumab maintenance","type":"EXPERIMENTAL"}],"collaborators":["Janssen Scientific Affairs, LLC"],"completion_date":{"date":"2027-08","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":95,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Lenalidomide","otherNames":[],"type":"DRUG"},{"name":"Daratumumab","otherNames":[],"type":"DRUG"},{"name":"Questionnaires","otherNames":[],"type":"BEHAVIORAL"},{"name":"Dietary Intervention","otherNames":[],"type":"OTHER"}],"last_update":"2026-09-15","lead_sponsor":"Memorial Sloan Kettering Cancer Center","official_title":"Daratumumab Versus Lenalidomide Maintenance Therapy for Multiple Myeloma: A Randomized Pilot Study Comparing Patient-Reported Health Related Quality of Life Measures With a Plant Based Nutrition Intervention Sub Study (NUTRIVENTION-4)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-08","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Difference in the global health status","timeFrame":"3 years"}],"references":[],"start_date":{"date":"2020-08-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide","url":"https://clinicaltrials.gov/study/NCT04497961"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nutrivention-4-nct04497961"}