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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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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

Locations
Austria
Medizinische Univ.-Klinik Graz
Graz, Austria, 8036
Klin. Abt. für Onkologie, AKH Wien
Vienna, Austria, 1090
Germany
Dept. of Hematology/Oncology, Charité Berlin
Berlin, Germany, 10098
Dept. of Internal Medicine A, University Muenster
Muenster, Germany, 48129
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, Germany, 80336
Dept. of Internal Medicine III, University of Ulm
Ulm, Germany, 89081
Dept. of Internal Medicine II, University of Wuerzburg
Wuerzburg, Germany, 97070
Italy
Regionalkrankenhaus Bozen
Bozen, Italy, 39100
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

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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 07, 2016