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ACTIVE NOT RECRUITING
NCT03292263
PHASE1/PHASE2

ASCT With Nivolumab in Patients With Multiple Myeloma

Sponsor: St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

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.

Official title: Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2017-04-24

Completion Date

2024-12-30

Last Updated

2024-05-07

Healthy Volunteers

No

Interventions

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

Locations (1)

Boris V Afanasyev, MD, Prof.

Saint Petersburg, Russia