Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Velcade in MALT Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373906
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : November 27, 2013
Information provided by:
Medical University of Vienna

Brief Summary:
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.

Condition or disease Intervention/treatment Phase
MALT Lymphoma Drug: Bortezomib (Velcade) Phase 2

Detailed Description:

The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation.

It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

Primary Outcome Measures :
  1. to evaluate the clinical potential of bortezomib
  2. to induce objective/histologic responses in patients with MALT-Lymphoma

Secondary Outcome Measures :
  1. to evaluate the impact of bortezomib on progression free survival

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV)
  • with first or greater relapse after HP-eradication, radiation or chemotherapy ,
  • age > 18 years
  • must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
  • ECOG status of <_ 2
  • must be capable of understanding the purpose of the study and given written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373906

Sponsors and Collaborators
Medical University of Vienna
Layout table for investigator information
Principal Investigator: Markus Raderer, Prof Department of Internal Medicine I

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00373906    
Other Study ID Numbers: Velcade-MALT-Lymphoma
Eudract No 2005-003077-25
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: May 2008
Keywords provided by Medical University of Vienna:
MALT Lymphoma, Bortezomib
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Stomach Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents