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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

August 28, 2020

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Multiple Myeloma
Interventions
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.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Commack (Limited protocol activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER