drugset / Trial / NCT03292263

ASCT With Nivolumab in Patients With Multiple Myeloma

NCT03292263

Phase 1/2 Unknown 30 enrolled St. Petersburg State Pavlov Medical University
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single center trial of Autologous Stem Cell Transplantation (ASCT) with nivolumab in multiple myeloma patients to determine the efficacy and safety of ASCT and PD1 inhibitor combination. For this purpose, 30 multiple myeloma patients, who have received induction therapy and have achieved a partial response (PR), stable disease (SD) or progression, and thus have unfavorable prognosis, will be treated with nivolumab administered iv at a dose of 100 mg on days 3 before and 17 after high-dose melphalan with autologous stem cell transplantation.

Timeline

Start
2017-04-24
Primary completion
2024-12-30
Completion
2024-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 70 mg/m2 Intravenous
Subject Melphalan Small molecule 100 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 100 mg Intravenous

Indications