ASCT With Nivolumab in Patients With Multiple Myeloma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Petersburg State Pavlov Medical University
• Treatments: Antibodies, Monoclonal; Melphalan; Nivolumab

Criteria

Inclusion Criteria:

• Subjects with MM (Multiple Myeloma)

• Partial response, stable disease or progression after induction therapy (including ASCT)

• Measurable disease

• Successful peripheral blood stem cell collection with G-CSF

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

• Signed informed consent

• Patients after first-line induction therapy

Exclusion Criteria:

• Another malignancy requiring treatment at the time of inclusion

• History of interstitial lung disease or pneumonitis

• Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension) which, in the opinion of the investigator could compromise participation in the study

• Uncontrolled bacterial or fungal infection at the time of enrollment

• Pregnancy

• Somatic or psychiatric disorder making the patient unable to sign informed consent

• Active or prior documented autoimmune disease requiring systemic treatment

• Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy