NCT03292263

ASCT With Nivolumab in Patients With Multiple Myeloma

Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Melphalan	iv infusion 70-100 mg/m2 on day -3, -2
DRUG	Nivolumab	iv infusion 100 mg on day -3, +17
PROCEDURE	Autologous Stem Cell Transplantation	peripheral blood stem cell transfusion at day 0

Timeline

• Start date: 2017-04-24
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2017-09-25
• Last updated: 2024-05-07

Locations

1 site across 1 country: Russia