NCT04497961

A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare maintenance therapy approaches in people with newly diagnosed multiple myeloma (MM) that has responded well to a first round of treatment. The researchers will compare giving the usual maintenance therapy (lenalidomide) with giving daratumumab as maintenance therapy, and they will look at which drug gives participants a better health-related quality of life during treatment. The researchers will measure participants' quality of life using various questionnaires. This study will help researchers find out whether this different approach of giving daratumumab as maintenance therapy is better, the same as, or worse than the usual approach.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide	dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle.
DRUG	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
BEHAVIORAL	Questionnaires	EORTC QLQ-C30, EORTC QLQ-MY20, PRO-CTCAE)
OTHER	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.

Timeline

• Start date: 2020-08-28
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2020-08-04
• Last updated: 2025-09-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study