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

NCT03385096 — Phase 2 / Phase 3, Unknown, 122 participants, Nanfang Hospital, Southern Medical University

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

Registry	NCT03385096
Status	Unknown
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	122 (Estimated)
Sponsor	Nanfang Hospital, Southern Medical University (Other); 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
Conditions	Autologous Hematopoietic Stem Cell Transplantation, Conditioning, Multiple Myeloma
Interventions	Busulfan (BU), Cyclophosphamide (CY), Etoposide (VP-16), Melphalan (Drug)
Dates	start 2018-01-02, primary completion 2020-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2017-12-28, last updated 2020-02-25
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BUCY+VP-16	Experimental	Drug: Busulfan (BU); Drug: Cyclophosphamide (CY); Drug: 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	Active comparator	Drug: Melphalan	For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.

Busulfan (BU) (Drug): Busulfan was administered at 3.2 mg/kg/day on days -8 to -6. -7 to -4.
Cyclophosphamide (CY) (Drug): Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Etoposide (VP-16) (Drug): Etoposide was administered at 10 mg/kg/day on days -3 to -2. -3 to -2.
Melphalan (Drug): Melphalan was administered at 200mg/m2 on day -2.

+Outcome measures

Primary outcomes

OS [3 year]: overall survival (OS)

Secondary outcomes

relapse rate relapse rate [3 year]: relapse rate
DFS [3 year]: disease-free survival (DFS)
TRM [3 year]: transplant-related mortality (TRM)

+Eligibility

Sex: All, ages: 14 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou, Guangdong	China	Recruiting