Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03875495
Status:
TERMINATED
Last Update Posted:
2022-01-28
First Post:
2019-03-13
Brief Title:
A Phase III Study Evaluating Temferon in Multiple Myeloma Patients With Early Relapse After Front Line Therapy TEM-MM
Sponsor:
Genenta Science
Organization:
Genenta Science
Study Overview
Official Title:
A Phase III Dose Escalation Study Evaluating Safety and Activity of Autologous CD34-Enriched Hematopoietic Progenitor Cells Genetically Modified With a Lentiviral Vector Encoding for the Human Interferon-ɑ2 Gene in Multiple Myeloma Patients With Early Relapse After Intensive Front Line Therapy
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized open label phase III dose-escalation study involving a single injection of Temferon an investigational advanced therapy consisting of autologous CD34-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid-specific interferon-ɑ2 expression which will be administered to up to 9 patients affected by multiple myeloma in early relapse after intensive front line treatment
Detailed Description:
This is a non-randomized open label single center phase III therapeutic exploratory dose-escalation prospective study involving a single intravenous infusion of Temferon an investigational advanced therapy consisting of autologous CD34-enriched hematopoietic stem and progenitor cells HSPCs exposed to transduction with a third-generation vesicular stomatitis virus-G VSV-G pseudo-typed lentiviral vector driving myeloid-specific interferon-ɑ2 IFN-ɑ2 expression which will be administered to up to 9 patients affected by multiple myeloma in early relapse after intensive front line treatment The study will recruit treat and follow-up patients at a specialist hematology and bone marrow transplantation unit at Ospedale San Raffaele OSR in Milan Italy
The study will enrol multiple myeloma patients that have experienced an early relapse after intensive front line treatment have been treated with an approved second line combination treatment regimen and obtained at least a very good partial remission VGPR according to International Myeloma Working Group IMWG criteria Once the written informed consent is obtained and screening procedures have been completed harvesting of HSPCs will occur Patients will be offered maintenance treatment during Temferon production and release Upon Temferon release for clinical use patients will be admitted to the transplantation unit for receipt of a reduced-intensity conditioning regimen consisting of melphalan This will be followed by autologous stem cell transplant ASCT and administration of Temferon In-patient monitoring will occur until hematological recovery occurs Thereafter regular follow-up of patients will occur up to 2 years 730 days At the 730 day visit patients will be invited to participate in a long term follow-up study which will last for an additional 6 years
3 cohorts of 3 patients will receive escalating doses of Temferon
In the event that MM disease progression occurs patients will be managed according to best clinical practice
The study will enrol multiple myeloma patients that have experienced an early relapse after intensive front line treatment have been treated with an approved second line combination treatment regimen and obtained at least a very good partial remission VGPR according to International Myeloma Working Group IMWG criteria Once the written informed consent is obtained and screening procedures have been completed harvesting of HSPCs will occur Patients will be offered maintenance treatment during Temferon production and release Upon Temferon release for clinical use patients will be admitted to the transplantation unit for receipt of a reduced-intensity conditioning regimen consisting of melphalan This will be followed by autologous stem cell transplant ASCT and administration of Temferon In-patient monitoring will occur until hematological recovery occurs Thereafter regular follow-up of patients will occur up to 2 years 730 days At the 730 day visit patients will be invited to participate in a long term follow-up study which will last for an additional 6 years
3 cohorts of 3 patients will receive escalating doses of Temferon
In the event that MM disease progression occurs patients will be managed according to best clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None