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ASCT With Nivolumab in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03292263
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ivan S Moiseev, St. Petersburg State Pavlov Medical University

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Drug: Nivolumab Procedure: Autologous Stem Cell Transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: Mel+Nivo
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
Drug: Melphalan
iv infusion 70-100 mg/m2 on day -3, -2
Other Name: Alkeran

Drug: Nivolumab
iv infusion 100 mg on day -3, +17
Other Name: Opdivo

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




Primary Outcome Measures :
  1. Overall response [ Time Frame: 3 months ]
    Includes complete response, very good partial response, and partial response (based on IMWG criteria)


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 12 months ]
    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.

  2. Overall Survival (OS) [ Time Frame: 24 months ]
    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)

  3. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 [ Time Frame: 12 months ]
    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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292263


Contacts
Contact: Boris V Afanasyev, MD, Prof. +78123386265 coordinatorbmt@gmail.com
Contact: Ivan S Moiseev, MD, PhD +79217961951 moisiv@mail.ru

Locations
Russian Federation
Boris V Afanasyev, MD, Prof. Recruiting
Saint Petersburg, Russian Federation, 197089
Contact: Olga V Pirogova, PhD    +79214419016    dr.pirogova@gmail.com   
Contact: Ivan S Moiseev, PhD    +79217961951    moisiv@mail.ru   
Sub-Investigator: Kirill V Lepik, MD         
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University

Responsible Party: Ivan S Moiseev, R.M.Gorbacheva memorial institute vice director for research, St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT03292263     History of Changes
Other Study ID Numbers: 11/17-n
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ivan S Moiseev, St. Petersburg State Pavlov Medical University:
Multiple Myeloma
Nivolumab
Melphalan
Autologous hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Melphalan
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents