ASCT With Nivolumab in Patients With Multiple Myeloma

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT03292263
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Melphalan — DRUG
    iv infusion 70-100 mg/m2 on day -3, -2
  • Nivolumab — DRUG
    iv infusion 100 mg on day -3, +17
  • Autologous Stem Cell Transplantation — PROCEDURE
    peripheral blood stem cell transfusion at day 0

Study Details

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.

Key Dates

Start date
Apr 24, 2017
Status verified
May 2024
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Overall response [ Time Frame: 3 months ]

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