ASCT With Nivolumab in Patients With Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    30
  • sponsor
    St. Petersburg State Pavlov Medical University
Updated on 24 March 2021
filgrastim
granulocyte colony stimulating factor
melphalan
measurable disease
cell transplantation
induction therapy
colony stimulating factor

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.

Details
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

Eligibility

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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note