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

Phase 2

• Conditions: Autologous Hematopoietic Stem Cell Transplantation; Multiple Myeloma; Conditioning
• Interventions: Drug: Busulfan (BU); Drug: Melphalan; Drug: Cyclophosphamide (CY); Drug: Etoposide (VP-16)

• Registration Number: NCT03385096
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-01-02
• Status Verified: 2019-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUCY+VP-16	Busulfan (BU)	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.
BUCY+VP-16	Cyclophosphamide (CY)	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.
BUCY+VP-16	Etoposide (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.
Melphalan	Melphalan	For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.

Primary Outcome Measures

Name	Time	Method
OS	3 year	overall survival (OS)

Secondary Outcome Measures

Name	Time	Method
TRM	3 year	transplant-related mortality (TRM)
DFS	3 year	disease-free survival (DFS)
relapse rate relapse rate	3 year	relapse rate

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China