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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Multiple Myeloma; Conditioning; Autologous Hematopoietic Stem Cell Transplantation

Treatments: Drug: Etoposide (VP-16); Drug: Melphalan; Drug: Busulfan (BU); Drug: Cyclophosphamide (CY)

Study type: Interventional

Funder types: Other

Identifiers

NCT03385096

Mel vs BUCY+VP-16-MM-2017

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

BUCY+VP-16

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide (CY)

Drug: Busulfan (BU)

Drug: Etoposide (VP-16)

Melphalan

Active Comparator group

Description:

For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.

Treatment:

Drug: Melphalan