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
Recruitment status was Recruiting
Sponsor:
University of Wuerzburg
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00311337
First received: April 3, 2006
Last updated: April 4, 2006
Last verified: March 2006
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Bortezomib
U.S. FDA Resources
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
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 Neoplasm, Residual 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 Neoplastic Processes Pathologic Processes Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013