Status:
ACTIVE_NOT_RECRUITING
ASCT With Nivolumab in Patients With Multiple Myeloma
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03292263
Start Date
April 24 2017
End Date
December 30 2024
Last Update
May 7 2024
Active Locations (1)
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1
Boris V Afanasyev, MD, Prof.
Saint Petersburg, Russia, 197089