Back to resultsASCT With Nivolumab in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Melphalan
Nivolumab
Autologous Stem Cell Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Nivolumab, Melphalan, Autologous hematopoietic stem cell transplantation
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
Sites / Locations
- Boris V Afanasyev, MD, Prof.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mel+Nivo
Arm Description
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
Outcomes
Primary Outcome Measures
Overall response
Includes complete response, very good partial response, and partial response (based on IMWG criteria)
Secondary Outcome Measures
Progression free survival (PFS)
PFS will be assessed with Kaplan-Meier method from the date of ASCT, with day 0 defined as date of stem cell infusion (in case of tandem transplant the 2nd of 2 transplants will be used) until the date of progression, defined as the date at which the patient starts the next line of therapy or the date of death.
Overall Survival (OS)
Will be assessed with Kaplan-Meier method from the date of ASCT, with day 0 defined as date of stem cell infusion (in case of tandem transplant the 2nd of 2 transplants will be used)
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Full Information
NCT ID
NCT03292263
First Posted
September 21, 2017
Last Updated
April 4, 2022
Sponsor
St. Petersburg State Pavlov Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03292263
Brief Title
ASCT With Nivolumab in Patients With Multiple Myeloma
Official Title
Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Nivolumab, Melphalan, Autologous hematopoietic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mel+Nivo
Arm Type
Experimental
Arm Description
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran
Intervention Description
iv infusion 70-100 mg/m2 on day -3, -2
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
iv infusion 100 mg on day -3, +17
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplantation
Intervention Description
peripheral blood stem cell transfusion at day 0
Primary Outcome Measure Information:
Title
Overall response
Description
Includes complete response, very good partial response, and partial response (based on IMWG criteria)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS will be assessed with Kaplan-Meier method from the date of ASCT, with day 0 defined as date of stem cell infusion (in case of tandem transplant the 2nd of 2 transplants will be used) until the date of progression, defined as the date at which the patient starts the next line of therapy or the date of death.
Time Frame
12 months
Title
Overall Survival (OS)
Description
Will be assessed with Kaplan-Meier method from the date of ASCT, with day 0 defined as date of stem cell infusion (in case of tandem transplant the 2nd of 2 transplants will be used)
Time Frame
24 months
Title
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Description
Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris V Afanasyev, MD, Prof.
Phone
+78123386265
Email
coordinatorbmt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan S Moiseev, MD, PhD
Phone
+79217961951
Email
moisiv@mail.ru
Facility Information:
Facility Name
Boris V Afanasyev, MD, Prof.
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga V Pirogova, PhD
Phone
+79214419016
Email
dr.pirogova@gmail.com
First Name & Middle Initial & Last Name & Degree
Ivan S Moiseev, PhD
Phone
+79217961951
Email
moisiv@mail.ru
First Name & Middle Initial & Last Name & Degree
Kirill V Lepik, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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ASCT With Nivolumab in Patients With Multiple Myeloma
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