Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT
Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedStudy Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 25, 2020
February 1, 2019
2.9 years
December 20, 2017
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
OS
overall survival (OS)
3 year
Secondary Outcomes (3)
relapse rate relapse rate
3 year
DFS
3 year
TRM
3 year
Study Arms (2)
BUCY+VP-16
EXPERIMENTALFor 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.
Melphalan
ACTIVE COMPARATORFor MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.
Interventions
Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Etoposide was administered at 10 mg/kg/day on days -3 to -2. -3 to -2.
Eligibility Criteria
You may qualify if:
- Multiple Myeloma patients
- Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Guangzhou First People's Hospitalcollaborator
- Zhujiang Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 20, 2017
First Posted
December 28, 2017
Study Start
January 2, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
February 25, 2020
Record last verified: 2019-02