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

February 24, 2020 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Department of Hematology,Nanfang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Busulfan (BU)

Busulfan was administered at 3.2 mg/kg/day on days -8 to -6.

-7 to -4.

Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
Drug: Etoposide (VP-16)

Etoposide was administered at 10 mg/kg/day on days -3 to -2.

-3 to -2.
Active Comparator: Melphalan
For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2.
Drug: Melphalan
Melphalan was administered at 200mg/m2 on day -2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 year
overall survival (OS)
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse rate relapse rate
Time Frame: 3 year
relapse rate
3 year
DFS
Time Frame: 3 year
disease-free survival (DFS)
3 year
TRM
Time Frame: 3 year
transplant-related mortality (TRM)
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mel vs BUCY+VP-16-MM-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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