NCT00984828

Brief Summary

The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then patients will be randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

6.8 years

First QC Date

September 23, 2009

Last Update Submit

September 6, 2016

Conditions

Multiple Myeloma

Keywords

multiple myelomaautologous stem cell transplantationvelcade

Outcome Measures

Primary Outcomes (1)

  • Response rate

    60 days and 2 years after the treatment

Secondary Outcomes (3)

  • Progression-free survival

    2 years

  • Overall survival

    2 years

  • Quality of life

    2 year

Study Arms (2)

vel 8 - ASCT

EXPERIMENTAL

8 cycles of velcade with ASCT

Drug: velcade

vel4 - ASCT

ACTIVE COMPARATOR

4 cycles of velcade with ASCT

Drug: velcade

Interventions

velcadeDRUG

velcade 1.3mg/m2 D1, 4, 8 and 11

Also known as: bortezomib
vel 8 - ASCTvel4 - ASCT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate
  • Measurable serum and/or urinary paraprotein
  • European Cooperative Oncology Group performance status 0-3
  • Serum bilirubin \< 1.5x the upper limit of normal (ULN) Serum alanine transaminase (ALT)/aspartate transaminase values \< 2.5 x ULN
  • Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

  • Woman of child bearing potential
  • Non-secretory MM
  • Serum creatinine \> 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy
  • Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
  • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zhi-Xiang Shen, M.D.

    Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 25, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)