Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT
NCT ID: NCT03385096
Last Updated: 2020-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
122 participants
INTERVENTIONAL
2018-01-02
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BUCY+VP-16
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.
Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -8 to -6.
-7 to -4.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Etoposide (VP-16)
Etoposide was administered at 10 mg/kg/day on days -3 to -2.
-3 to -2.
Melphalan
For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.
Melphalan
Melphalan was administered at 200mg/m2 on day -2.
Interventions
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Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -8 to -6.
-7 to -4.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Etoposide (VP-16)
Etoposide was administered at 10 mg/kg/day on days -3 to -2.
-3 to -2.
Melphalan
Melphalan was administered at 200mg/m2 on day -2.
Eligibility Criteria
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Inclusion Criteria
* Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells
Exclusion Criteria
* Patients with any conditions not suitable for the trial (investigators' decision
14 Years
65 Years
ALL
No
Sponsors
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Guangzhou First People's Hospital
OTHER
Zhujiang Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Mel vs BUCY+VP-16-MM-2017
Identifier Type: -
Identifier Source: org_study_id
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