Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Status:
Recruiting
Trial end date:
2026-10-01
Target enrollment:
Participant gender:
Summary
Multiple myeloma (MM) is the second most common hematologic malignancy with an estimated
annual incidence of nearly 35,000 cases. While still considered an incurable disease, new
treatments have improved outcomes dramatically over the last two decades. Around the turn of
the millennium, classical cytotoxic chemotherapy and radiation were the only available
treatment modalities and median OS was estimated at 2-3 years. Currently, there are now 17
FDA-approved anti-myeloma agents and median OS is approaching 10 years. More recently, next
generation cellular and immune therapies are demonstrating unprecedented efficacy in highly
refractory patients with otherwise a very short life expectancy. In this study, the starting
dose of ixazomib will be reduced to 3mg, as this is the first FDA-recommended dose
recommendation (from 4mg). The starting dose of mezigdomide will be 0.6mg. Frequent toxicity
and AE monitoring as outlined in this trial (weekly in C1, every 2 weeks in C2-C4) asserts
maximization of patient safety. Dexamethasone (DEX) will be dosed at 40mg weekly in patients
< 75 years old and 20mg for patients > 76 years old. Additionally, the staring dose of DEX
may be reduced to 20mg in any patient, per study provider discretion, based on several
factors such frailty, prior adverse side effects or existing comorbidities.