95
Participants
Start Date
August 28, 2020
Primary Completion Date
August 31, 2026
Study Completion Date
August 31, 2026
Lenalidomide
dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle.
Daratumumab
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
Questionnaires
EORTC QLQ-C30, EORTC QLQ-MY20, PRO-CTCAE)
Dietary Intervention
The intervention, consisting of fully prepared whole foods plant based (WFPBD) meals and behavioral coaching provided by Daily Harvest. Patients receive self-selected WFPBD meals (lunch/dinner) for 12 weeks, along with guidance for snacks and breakfast. Behavioral counseling will be provided by health coaches and a research dietitian. The first 15 participants on each arm interested in this intervention will be enrolled on C13D1 or C25D1.
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
Memorial Sloan Kettering Commack (Limited protocol activities), Commack
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Janssen Scientific Affairs, LLC
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER