Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425276
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Evaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation
Sponsor:
CASI Pharmaceuticals China Co Ltd
Organization:
CASI Pharmaceuticals China Co Ltd
Study Overview
Official Title:
A Multicenter Open-Label Safety and Efficacy Study of High Dose Melphalan Hydrochloride for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if high-dose Melphalan HCl for Injection works to treat multiple myeloma It will also learn about the safety of high dose Melphalan HCl for Injection The main questions it aims to answer are
Does high-dose Melphalan HCl for Injection deplete bone marrow activity which results in a better outcome of patientsown stem cell blood-forming cell transplantation What medical problems do participants have when taking high-dose Melphalan HCl for Injection How fast is the high-dose Melphalan HCl for Injection cleared out from blood
Participants will
Take high-dose Melphalan HCl for Injection for 2 days
Have stem cell transplantation one day after treatment
Stay in the hospital for at least 10days and visit the clinic once every week for the first month after transplantation and every month after for checkups and tests
Does high-dose Melphalan HCl for Injection deplete bone marrow activity which results in a better outcome of patientsown stem cell blood-forming cell transplantation What medical problems do participants have when taking high-dose Melphalan HCl for Injection How fast is the high-dose Melphalan HCl for Injection cleared out from blood
Participants will
Take high-dose Melphalan HCl for Injection for 2 days
Have stem cell transplantation one day after treatment
Stay in the hospital for at least 10days and visit the clinic once every week for the first month after transplantation and every month after for checkups and tests
Detailed Description:
Autologous stem cell transplantation ASCT is a standard of care in transplant-eligible MM patients which has been demonstrated with a better complete remission rate CR and with longer survival High-dose melphalan 200 mgm2 has been the most commonly used conditioning regimen for ASCT in MM EVOMELA melphalan HCl for Injection stabilized with Captisol a specially modified cyclodextrin has been believed to have better solubility and stability upon reconstitution which result in decreased toxicity increased convenience and flexibility of administration without comprising efficacious data Melphalan HCl for Injection has been approved by NMPA as a standard conditioning drug for ASCT in MM patients The current study evaluated the efficacy safety and PK profile for high-dose Melphalan HCl for Injection as a myeloablative conditioning regimen in Chinese symptomatic transplant-eligible MM patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None