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Status unknownNCT03385096Updated Feb 25, 2020

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

A Phase 2/3 interventional study of Busulfan (BU) and Cyclophosphamide (CY) in Autologous Hematopoietic Stem Cell Transplantation, Conditioning and Multiple Myeloma, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Nanfang Hospital, Southern Medical University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
14 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Autologous Hematopoietic Stem Cell Transplantation
  • Conditioning
  • Multiple Myeloma

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03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 122 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

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Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Multiple Myeloma patients
  • Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (estimated)

Study arms

  • 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) · Drug: Cyclophosphamide (CY) · Drug: Etoposide (VP-16)

  • Active comparator
    Melphalan

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

    Drug: Melphalan

Interventions

  • Busulfan was administered at 3.2 mg/kg/day on days -8 to -6. -7 to -4.

  • Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.

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

  • Melphalan was administered at 200mg/m2 on day -2.

06

What researchers measure

Primary outcomes

  1. OS

    overall survival (OS)

    Time frame: 3 year

Secondary outcomes

  1. relapse rate relapse rate

    relapse rate

    Time frame: 3 year

  2. DFS

    disease-free survival (DFS)

    Time frame: 3 year

  3. TRM

    transplant-related mortality (TRM)

    Time frame: 3 year

07

Study locations

1 of 1 sites recruiting
  • Department of Hematology,Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    Recruiting
    • Li Xuan · Contact356135708@qq.com · +86-020-62787883
    • Qifa Liu · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Dec 2020, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Dec 28, 2017
StartActual
Jan 2, 2018
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2021
Last update
Feb 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03385096
Responsible party
Qifa Liu (Professor, Nanfang Hospital, Southern Medical University) — Principal investigator
First posted
Dec 28, 2017
Start date
Jan 2, 2018
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Feb 25, 2020

Study contacts

Qifa Liu
Contact
liuqifa628@163.com
+862061641611

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Busulfan · Cyclophosphamide · Etoposide

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