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Velcade in MALT Lymphoma Patients

This study has been completed.
Information provided by:
Medical University of Vienna Identifier:
First received: September 7, 2006
Last updated: November 26, 2013
Last verified: May 2008
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.

Condition Intervention Phase
MALT Lymphoma Drug: Bortezomib (Velcade) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

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

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

Estimated Enrollment: 16
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00373906

Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Markus Raderer, Prof Department of Internal Medicine I
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00373906     History of Changes
Other Study ID Numbers: Velcade-MALT-Lymphoma
Eudract No 2005-003077-25
Study First Received: September 7, 2006
Last Updated: November 26, 2013

Keywords provided by Medical University of Vienna:
MALT Lymphoma, Bortezomib

Additional relevant 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 processed this record on August 18, 2017