drugset / Trial / NCT04918511

A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma

NCT04918511 ↗

Phase 1 Withdrawn Oncopeptides AB
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of a single infusion of OPD5 before Autologous Stem Cell Transplant in patients with RRMM. The study will evaluate increasing doses of OPD5 to find the best dose and to assess any side effects. Each patient will be assigned to a dose cohort of 3-6 patients to receive one single dose of OPD5. Each patient will be hospitalized for about 14 days from the OPD5 infusion and then have monthly visits to the clinic for 3 months and then every third month until disease progression or starting new myeloma treatment, maximum up to 2 years.

Timeline

Start
2021-05-27
Primary completion
2024-03
Completion
2025-12

Outcome

Outcome not reported

Stopped: “Sponsor made the decision to terminate the COAST study to refocus the OPD5 clinical program.”

Drugs

EvaluationDrugModalityDoseRoute
Subject OPD5 Unknown 30 mg/m2 Intravenous

Indications