ASCT With Nivolumab in Patients With Multiple Myeloma

NCT ID: NCT03292263

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2024-12-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mel+Nivo

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

Group Type: EXPERIMENTAL

Melphalan

Intervention Type: DRUG

iv infusion 70-100 mg/m2 on day -3, -2

Nivolumab

Intervention Type: DRUG

iv infusion 100 mg on day -3, +17

Autologous Stem Cell Transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transfusion at day 0

Interventions

Melphalan

iv infusion 70-100 mg/m2 on day -3, -2

Intervention Type: DRUG

Nivolumab

iv infusion 100 mg on day -3, +17

Intervention Type: DRUG

Autologous Stem Cell Transplantation

peripheral blood stem cell transfusion at day 0

Intervention Type: PROCEDURE

Other Intervention Names

Alkeran; Opdivo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ivan S Moiseev

R.M.Gorbacheva memorial institute vice director for research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boris V Afanasyev, MD, Prof.

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

11/17-n

Identifier Type: -

Identifier Source: org_study_id