Back to resultsMel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT
Primary Purpose
Autologous Hematopoietic Stem Cell Transplantation, Conditioning, Multiple Myeloma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Busulfan (BU)
Cyclophosphamide (CY)
Etoposide (VP-16)
Melphalan
Sponsored by
About this trial
This is an interventional treatment trial for Autologous Hematopoietic Stem Cell Transplantation
Eligibility Criteria
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
Sites / Locations
- Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BUCY+VP-16
Melphalan
Arm Description
For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.
For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.
Outcomes
Primary Outcome Measures
OS
overall survival (OS)
Secondary Outcome Measures
relapse rate relapse rate
relapse rate
DFS
disease-free survival (DFS)
TRM
transplant-related mortality (TRM)
Full Information
NCT ID
NCT03385096
First Posted
December 20, 2017
Last Updated
February 24, 2020
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Guangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT03385096
Brief Title
Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT
Official Title
Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Guangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autologous Hematopoietic Stem Cell Transplantation, Conditioning, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BUCY+VP-16
Arm Type
Experimental
Arm Description
For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2.
Arm Title
Melphalan
Arm Type
Active Comparator
Arm Description
For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.
Intervention Type
Drug
Intervention Name(s)
Busulfan (BU)
Intervention Description
Busulfan was administered at 3.2 mg/kg/day on days -8 to -6.
-7 to -4.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (CY)
Intervention Description
Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Intervention Type
Drug
Intervention Name(s)
Etoposide (VP-16)
Intervention Description
Etoposide was administered at 10 mg/kg/day on days -3 to -2.
-3 to -2.
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Melphalan was administered at 200mg/m2 on day -2.
Primary Outcome Measure Information:
Title
OS
Description
overall survival (OS)
Time Frame
3 year
Secondary Outcome Measure Information:
Title
relapse rate relapse rate
Description
relapse rate
Time Frame
3 year
Title
DFS
Description
disease-free survival (DFS)
Time Frame
3 year
Title
TRM
Description
transplant-related mortality (TRM)
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qifa Liu
Phone
+862061641611
Email
liuqifa628@163.com
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xuan
Phone
+86-020-62787883
Email
356135708@qq.com
First Name & Middle Initial & Last Name & Degree
Qifa Liu
12. IPD Sharing Statement
Learn more about this trial
Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT
We'll reach out to this number within 24 hrs