ASCT With Nivolumab in Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03292263
• Other study ID #: 11/17-n
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 24, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Melphalan
iv infusion 70-100 mg/m2 on day -3, -2
• Nivolumab
iv infusion 100 mg on day -3, +17

Procedure:
• Autologous Stem Cell Transplantation
peripheral blood stem cell transfusion at day 0

Locations

Country	Name	City	State
Russian Federation	Boris V Afanasyev, MD, Prof.	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response	Includes complete response, very good partial response, and partial response (based on IMWG criteria)	3 months
Secondary	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.	12 months
Secondary	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)	24 months
Secondary	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).	12 months