NCT00416273

Brief Summary

The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P25-P50 for phase_3 multiple-myeloma

Timeline
Completed

Started Dec 2006

Typical duration for phase_3 multiple-myeloma

Geographic Reach
1 country

38 active sites

Status
completed

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

December 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

6.4 years

First QC Date

December 22, 2006

Last Update Submit

March 5, 2015

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaBortezomibPS341Proteasome inhibitorConsolidation therapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with event-free survival (PFS)

    From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled

Secondary Outcomes (10)

  • Number of patients with event free survival (EFS)

    From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled

  • Response rates

    Up to Week 25

  • Overall survival

    From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled

  • Time to progression

    From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled

  • Duration of response

    Up to Week 25

  • +5 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Participants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.

Drug: Bortezomib

Observation group

EXPERIMENTAL

Participants in the observation group will not receive any consolidation therapy.

Drug: No intervention

Interventions

BortezomibDRUG

Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.

Treatment group
No interventionDRUG

Participants in the observation group will be observed and will not receive any consolidation therapy.

Observation group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
  • Women must be postmenopausal or using safe contraception methods
  • Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges

You may not qualify if:

  • No asecretory multiple myeloma
  • History of allergic reactions to bortezomib or mannitol
  • Expected life expectancy of less than 3 months
  • No other malignant disease beside basalioma either existing or history of
  • No history of severe cardio-pulmonary disease
  • Seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

Unknown Facility

Augsburg, Germany

Location

Unknown Facility

Bamberg, Germany

Location

Unknown Facility

Berg, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bremen, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Duisburg, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Eschweiler, Germany

Location

Unknown Facility

Frankfurt am Main, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Goch, Germany

Location

Unknown Facility

Göttingen, Germany

Location

Unknown Facility

Greifswald, Germany

Location

Unknown Facility

Halle, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hamm, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Homburg, Germany

Location

Unknown Facility

Jena, Germany

Location

Unknown Facility

Karlsruhe, Germany

Location

Unknown Facility

Kempten, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Magdeburg, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Mutlangen, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Nuremberg, Germany

Location

Unknown Facility

Oldenburg, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Rostock, Germany

Location

Unknown Facility

Stuttgart, Germany

Location

Unknown Facility

Ulm, Germany

Location

Unknown Facility

Villingen-Schwenningen, Germany

Location

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Würzburg, Germany

Location

Related Publications (2)

  • Straka C, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Fischer T, Liebisch P, Engelhardt M, Einsele H. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. Eur J Haematol. 2019 Sep;103(3):255-267. doi: 10.1111/ejh.13281. Epub 2019 Jul 19.

    PMID: 31231828DERIVED

  • Einsele H, Knop S, Vogel M, Muller J, Kropff M, Metzner B, Langer C, Sayer H, Jung W, Durk HA, Salwender H, Wandt H, Bassermann F, Gramatzki M, Rosler W, Wolf HH, Brugger W, Engelhardt M, Fischer T, Liebisch P, Straka C. Response-adapted consolidation with bortezomib after ASCT improves progression-free survival in newly diagnosed multiple myeloma. Leukemia. 2017 Jun;31(6):1463-1466. doi: 10.1038/leu.2017.83. Epub 2017 Mar 15. No abstract available.

    PMID: 28293022DERIVED

Related Links

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

  • Janssen-Cilag G.m.b.H, Germany Clinical Trial

    Janssen-Cilag G.m.b.H

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 27, 2006

Study Start

December 1, 2006

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

DE(38)