Phase IIIa Study of ODX OsteoDex Treatment in Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are studying ODX OsteoDex in people with relapsed or refractory multiple myeloma to evaluate its safety and biological effects. This phase IIIa, multi-center, open-label trial tests up to three increasing dose levels of ODX to find the best tolerated dose and gather early evidence of how it affects the disease and related biomarkers. The trial also explores the time to disease progression by tracking specific blood proteins. Participants receive ODX treatment every two weeks for up to seven doses, unless they experience unacceptable side effects or disease progression. There are three dose groups 3.0 mgkg, 6.0 mgkg, and 9.0 mgkg. The study includes a screening period, a treatment period with visits including telephone contacts, and a follow-up visit two weeks after the last dose. Dose escalation decisions are based on safety data reviewed after initial patient dosing. During the study, participants will undergo safety and tolerability monitoring over 14 weeks, including assessments of treatment-related side effects and disease response using established criteria. Researchers will also measure changes in blood markers related to the disease and bone metabolism. Follow-up visits will track any progression of the disease. The trial aims to provide detailed safety and early efficacy information to guide future treatment development.

Study of ODX (OsteoDex) in Multiple Myeloma