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ASCT With Nivolumab in Patients With Multiple Myeloma

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03292263
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 St. Petersburg State Pavlov Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma
Arms & Interventions

Arms

Experimental: Mel+Nivo

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

Interventions

Drug: - Melphalan

iv infusion 70-100 mg/m2 on day -3, -2

Drug: - Nivolumab

iv infusion 100 mg on day -3, +17

Procedure: - Autologous Stem Cell Transplantation

peripheral blood stem cell transfusion at day 0

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Boris V Afanasyev, MD, Prof., Saint Petersburg, Russian Federation

Status

Recruiting

Address

Boris V Afanasyev, MD, Prof.

Saint Petersburg, , 197089

Site Contact

Olga V Pirogova, PhD

dr.pirogova@gmail.com

+79214419016

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