NCT00311337

Brief Summary

Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Oct 2005

Typical duration for phase_2 multiple-myeloma

Geographic Reach
3 countries

8 active sites

Status
unknown

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

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 5, 2006

Status Verified

March 1, 2006

First QC Date

April 3, 2006

Last Update Submit

April 4, 2006

Conditions

Multiple Myeloma

Keywords

VELCADEbortezomibmaintenance treatmentmultiple myelomaprimary disease

Outcome Measures

Primary Outcomes (1)

  • Primary endpoints are to study the safety of four cycles of VELCADE in patients with multiple myeloma following high-dose chemotherapy and autologous PBSCT.

Secondary Outcomes (4)

  • The secondary objectives of this study are to assess the efficacy of four cycles of VELCADE at two different dose levels as maintenance treatment in patients with multiple myeloma

  • and detectable residual disease following high-dose chemotherapy and autologous PBSCT

  • to assess the 2 year progression-free survival

  • and to assess the 2 year overall survival.

Interventions

bortezomibDRUG

Eligibility Criteria

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

You may qualify if:

  • Patient must agree to participate in the study.
  • Patient agrees to use an appropriate method of contraception.
  • Willingness and ability to comply with the study protocol for the duration of the study

You may not qualify if:

  • Patient showing signs of disease progression
  • Patient has a platelet count \< 100 x 10\^9/L within 14 days before enrollment.
  • Patient has an absolute neutrophil count \< 1.0 x 10\^9/L within 14 days before enrollment.
  • Patient has a calculated or measured creatinine clearance \< 30 mL/minute within 14 days before enrollment.
  • Patient has \>= Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Patient has hypersensitivity to bortezomib, boron, or mannitol.
  • Patient has received prior treatment with bortezomib
  • Patient is pregnant or nursing
  • Patient has received other investigational drugs within 14 days before enrollment
  • Patient has progressive disease
  • Patient has a Karnofsky performance status \< 60%
  • Patient has a life expectancy of \< 3 months
  • Patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids
  • Patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medizinische Univ.-Klinik Graz

Graz, 8036, Austria

RECRUITING

Klin. Abt. für Onkologie, AKH Wien

Vienna, 1090, Austria

RECRUITING

Dept. of Hematology/Oncology, Charité Berlin

Berlin, 10098, Germany

RECRUITING

Dept. of Internal Medicine, Ludwig-Maximilian-University Munich

Munich, 80336, Germany

RECRUITING

Dept. of Internal Medicine A, University Muenster

Münster, 48129, Germany

RECRUITING

Dept. of Internal Medicine III, University of Ulm

Ulm, 89081, Germany

RECRUITING

Dept. of Internal Medicine II, University of Wuerzburg

Würzburg, 97070, Germany

RECRUITING

Regionalkrankenhaus Bozen

Bolzano, 39100, Italy

RECRUITING

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

  • Hermann Einsele, MD

    Dept. of Internal Medicine II, University of Wuerzburg, Klinikstr. 6-8, 97070 Wuerzburg

    PRINCIPAL INVESTIGATOR

  • Hermann Einsele, MD

    Dept. of Internal Medicine, University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermann Einsele, MD

CONTACT

+49-931-20170011einsele_h@klinik.uni-wuerzburg.de

Holger Hebart, MD

CONTACT

+49 7071 2984477hrhebart@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

October 1, 2005

Study Completion

October 1, 2010

Last Updated

April 5, 2006

Record last verified: 2006-03

Locations

IT(1)DE(5)AU(2)