ASCT With Nivolumab in Patients With Multiple Myeloma

St. Petersburg State Pavlov Medical University

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Procedure: Autologous Stem Cell Transplantation; Drug: Melphalan; Drug: Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03292263

11/17-n

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Mel+Nivo

Experimental group

Description:

Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m\^2, Nivolumab100 mg iv days -3, +17

Treatment:

Drug: Nivolumab

Drug: Melphalan

Procedure: Autologous Stem Cell Transplantation