VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by University of Wuerzburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00311337
First received: April 3, 2006
Last updated: April 4, 2006
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following High-Dose Melphalan Treatment and Autologous PBSCT (Minimal Residual Disease, Partial Remission or Stable Disease)

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 61
Study Start Date: October 2005
Estimated Study Completion Date: October 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient having received tandem transplants with high-dose melphalan and autologous PBSCT within 3-6 months prior to inclusion into this protocol
  • Patients with measurable minimal residual disease (very good partial remission [VGPR]) or patients in partial remission (PR) or patients with stable disease (SD) at the time of inclusion in the study
  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311337

Contacts
Contact: Hermann Einsele, MD +49-931-20170011 einsele_h@klinik.uni-wuerzburg.de
Contact: Holger Hebart, MD +49 7071 2984477 hrhebart@med.uni-tuebingen.de

Locations
Austria
Medizinische Univ.-Klinik Graz Recruiting
Graz, Austria, 8036
Contact: Werner Linkesch, MD    ++43(0)316/385-4086    werner.linkesch@kfunigraz.ac   
Principal Investigator: Werner Linkesch, MD         
Klin. Abt. für Onkologie, AKH Wien Recruiting
Vienna, Austria, 1090
Contact: Johannes Drach, MD       heinz.gisslinger@akh-wien.ac.at   
Principal Investigator: Johannes Drach, MD         
Germany
Dept. of Hematology/Oncology, Charité Berlin Recruiting
Berlin, Germany, 10098
Contact: Orhan Sezer, MD    030/450-513105    sezer@charite.de   
Principal Investigator: Orhan Sezer, MD         
Dept. of Internal Medicine A, University Muenster Recruiting
Muenster, Germany, 48129
Contact: Martin Kropff, MD       kropff@uni-muenster.de   
Sub-Investigator: Martin Kropff, MD         
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich Recruiting
Munich, Germany, 80336
Contact: Christian Straka, MD    089/5160-2278    cstraka@medinn.med.uni-muenchen.de   
Principal Investigator: Christian Straka, MD         
Dept. of Internal Medicine III, University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Peter Liebisch, MD    0731/500-33809    peter.liebisch@medizin.uni-ulm.de   
Principal Investigator: Peter Liebisch, MD         
Dept. of Internal Medicine II, University of Wuerzburg Recruiting
Wuerzburg, Germany, 97070
Contact: Hermann Einsele, MD    +4993120170011    einsele_h@klinik.uni-wuerzburg.de   
Sub-Investigator: Volker Kunzmann, MD         
Sub-Investigator: Stefan Knop, MD         
Italy
Regionalkrankenhaus Bozen Recruiting
Bozen, Italy, 39100
Contact: Paolo Coser, MD    0039/471/908807    emat@asbz.it   
Principal Investigator: Paolo Coser, MD         
Sponsors and Collaborators
University of Wuerzburg
Investigators
Principal Investigator: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311337     History of Changes
Other Study ID Numbers: DSMM VIII
Study First Received: April 3, 2006
Last Updated: April 4, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:
VELCADE
bortezomib
maintenance treatment
multiple myeloma
primary disease

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014