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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
During the Study Period, patients will receive Melphalan HCl for Injection dosed at 100 mg/m2 on Day -3 and Day -2.
Peking University People's Hospital
Beijing, China
Rate of patients achieveing myeloablation
To record the percentage of patients who achieve myeloablation which is defined as absolute neutrophil count \[ANC\] \<0.5 × 109/L, absolute lymphocyte count \[ALC\] \<0.1 × 109/L, or platelet count \<20,000/mm3 in 2 consecutive daily assessments.
Time frame: 95±5 days after ASCT
Time to achieveing myeloablation
To record the time, in days, from the date of first dose of High-dose Melphalan HCL for Injection to the date of myoloablation which is defined as absolute neutrophil count \[ANC\] \<0.5 × 109/L, absolute lymphocyte count \[ALC\] \<0.1 × 109/L, or platelet count \<20,000/mm3 in 2 consecutive daily assessments.
Time frame: 95±5 days after ASCT
Time to achieveing neutrophil engraftment
To record the time, in days, from the date of Auto-HSCT to the date when absolute neutrophil count (ANC) \>0.5 × 109/L in 3 consecutive daily assessments.
Time frame: 95±5 days after ASCT
Time to achieving platelet engraftment
To record the time, in days, from the date of Auto-HSCT to the date when untransfused platelet measurement \>20,000/mm3 in 3 consecutive daily assessments.
Time frame: 95±5 days after ASCT
Incidence of Treatment-related Motality (TRM)
To characterize the safety, tolerability of High-dose Melphalan HCL for Myeloablation in MM Patients With Auto-HSC Transplantation by recording the incidence of death without relapse or progression of the disease.
Time frame: 95±5 days after ASCT
Incidence and severity of AEs and SAEs, including changes in laboratory values
To characterize the safety, tolerability of High-dose Melphalan HCL for Injection for Myeloablation in MM Patients With Auto-HSC Transplantation.
Time frame: 95±5 days after ASCT
Overall Response (ORR)
Response assessment per International Myeloma Working Group (IMWG) criteria
Time frame: 95±5 days after ASCT
Tmax of Melphalan HCL for Injection derived from plasma concentrations
Tmax of Melphalan HCL for Injection derived from plasma concentrations of each administration
Time frame: 24 Hours
T1/2 of Melphalan HCL for Injection derived from plasma concentrations
T1/2 of Melphalan HCL for Injection derived from plasma concentrations of each administration
Time frame: 24 Hours
Cmax of Melphalan HCL for Injection derived from plasma concentrations
Cmax of Melphalan HCL for Injection derived from plasma concentrations of each administration
Time frame: 24 Hours
AUC of Melphalan HCL for Injection derived from plasma concentrations
AUC of Melphalan HCL for Injection derived from plasma concentrations of each administration
Time frame: 24 Hours
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