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Evaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation

Multiple Myeloma Clinical Trial

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

Clinical Trial 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 patients'own 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.

Clinical Trial 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 mg/m2) 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06425276
Study type Interventional
Source CASI Pharmaceuticals (China) Co., Ltd.
Contact
Status Completed
Phase Phase 4
Start date July 24, 2020
Completion date September 18, 2021
View Details
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