ASCT With Nivolumab in Patients With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03292263|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
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)|
|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|
U.S. FDA Resources
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
iv infusion 70-100 mg/m2 on day -3, -2
Other Name: AlkeranDrug: Nivolumab
iv infusion 100 mg on day -3, +17
Other Name: OpdivoProcedure: Autologous Stem Cell Transplantation
peripheral blood stem cell transfusion at day 0
- Overall response [ Time Frame: 3 months ]Includes complete response, very good partial response, and partial response (based on IMWG criteria)
- 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.
- 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)
- 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).
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
|Contact: Boris V Afanasyev, MD, Prof.||+firstname.lastname@example.org|
|Contact: Ivan S Moiseev, MD, PhDemail@example.com|
|Boris V Afanasyev, MD, Prof.||Recruiting|
|Saint Petersburg, Russian Federation, 197089|
|Contact: Olga V Pirogova, PhD +79214419016 firstname.lastname@example.org|
|Contact: Ivan S Moiseev, PhD +79217961951 email@example.com|
|Sub-Investigator: Kirill V Lepik, MD|