A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma
Categories (click each to see list of all clinical trials associated with that category): Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Wildes, Tanya
Eligibility: https://clinicaltrials.gov/study/NCT04009109?term=NCT04009109&rank=1
Summary
Primary
To assess the impact on progression-free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment after induction therapy with lenalidomide, ixazomib, dexamethasone, and daratumumab.
Secondary
To examine minimal residual disease (MRD).
To assess the toxicity profile of treatment arm.
To assess overall response rate (ORR).
To examine overall survival (OS) within in each treatment arm.
To assess quality of life using the following questionnaires:
o EQ 5D 5L,
o EORTC QLQ-MY20,
o EORTC QLQ-C30.
To measure the rate of adherence to lenalidomide and ixazomib during first 12 cycles.
To describe functional status, comorbidity, psychological state, social activity, social support, and nutrition using the geriatric assessment tool.
To determine whether geriatric assessment variables known to be associated with chemotherapy toxicity in other disease groups can also predict therapy-associated toxicity in the MM population.
Exploratory
Changes in body composition after completion of induction therapy using DXA scans at baseline and after 12 cycles.
To evaluate circulating MM cells and circulating DNA