ASCT With Nivolumab in Patients With Multiple Myeloma

NCT03292263 | Active Not Recruiting Phase 1

• 1 other identifier: 11/17-n
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Multiple Myeloma; Nivolumab; Melphalan; Autologous hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Overall response

  Includes complete response, very good partial response, and partial response (based on IMWG criteria)

  3 months

Secondary Outcomes (3)

• Progression free survival (PFS)

  12 months

• Overall Survival (OS)

  24 months

• Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

  12 months

Study Arms (1)

Mel+Nivo

EXPERIMENTAL

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

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

Interventions

Melphalan DRUG

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

Also known as: Alkeran

Mel+Nivo

Nivolumab DRUG

iv infusion 100 mg on day -3, +17

Also known as: Opdivo

Mel+Nivo

Autologous Stem Cell Transplantation PROCEDURE

peripheral blood stem cell transfusion at day 0

Mel+Nivo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

Boris V Afanasyev, MD, Prof.

Saint Petersburg, 197089, Russia

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan; Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R.M.Gorbacheva memorial institute vice director for research

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: April 24, 2017
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

RU (1)