ASCT With Nivolumab in Patients With Multiple Myeloma

  • End date
    Dec 24, 2022
  • participants needed
  • sponsor
    St. Petersburg State Pavlov Medical University
Updated on 24 March 2021
granulocyte colony stimulating factor
measurable disease
cell transplantation
induction therapy
colony stimulating factor


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.

Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment melphalan, Nivolumab, autologous stem cell transplantation
Clinical Study IdentifierNCT03292263
SponsorSt. Petersburg State Pavlov Medical University
Last Modified on24 March 2021


Yes No Not Sure

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
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
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