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NCT03385096 Clinical Trial

Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT

Multiple Myeloma Clinical Trial

Official title:
Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03385096
Other study ID # Mel vs BUCY+VP-16-MM-2017
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 2, 2018
Est. completion date December 2021

Study information
Verified date February 2019
Source Nanfang Hospital of Southern Medical University
Contact Qifa Liu
Phone +862061641611
Email liuqifa628@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 122
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
China Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (5)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary OS overall survival (OS) 3 year
Secondary relapse rate relapse rate relapse rate 3 year
Secondary DFS disease-free survival (DFS) 3 year
Secondary TRM transplant-related mortality (TRM) 3 year
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