Autologous Hematopoietic Stem Cell Transplantation, Conditioning, Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16 myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic stem cell transplantation.
Interventions
Etoposide was administered at 10 mg/kg/day on days -3 to -2. -3 to -2.
DRUGMelphalan
Melphalan was administered at 200mg/m2 on day -2.
DRUGBusulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -8 to -6. -7 to -4.
Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Sponsors
Guangzhou First People's Hospital
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Multiple Myeloma patients * Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells
Exclusion criteria
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3 year | overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relapse rate relapse rate | 3 year | relapse rate |
| DFS | 3 year | disease-free survival (DFS) |
| TRM | 3 year | transplant-related mortality (TRM) |
Countries
China
Contacts
Primary ContactQifa Liu
Outcome results
None listed