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Sponsored by: |
Janssen-Cilag G.m.b.H |
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Information provided by: | Janssen-Cilag G.m.b.H |
ClinicalTrials.gov Identifier: | NCT00416208 |
The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Other: Observation Drug: Bortezomib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75 |
Estimated Enrollment: | 385 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: Bortezomib
1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
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002: No Intervention |
Other: Observation
Observational arm
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No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma patients are available.
Ínterferon tested as consolidation / maintenance therapy has not uniformly proven to prolong survival. In this study the hypothesis is being tested that bortezomib is able to increase duration of response and thus improving survival. This hypothesis is based on the results of the approval study where bortezomib has been tested to improve these endpoints.This is a multicenter, open-label, randomized (patients are assigned to different treatment group by chance) phase III study to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75. Three months after receiving high dose melphalan with autologous stem cell transplantation patients will be randomized to receive either consolidation therapy with bortezomib or to be monitored without consolidation therapy. Subjects in the consolidation group will be treated up to 4 cycles (6 weeks each). The main study phase has a duration of 24 weeks. The trial ends after the last enrolled patient has completed a follow-up period of 30 months. The primary objective is to determine the event free survival in treatment and observation group. The secondary objectives are to assess the response rate, overall survival, duration of response, time to progression, short- and long-term toxicities, quality of life and cytogenetic analyses with regard to treatment response, event free survival and overall survival. Primary efficacy analysis: Event free survival is defined as the time from the first disease-related therapeutic procedure until death, progress or relapse. Secondary efficacy analyses: response rate of the treatment group (measured by the relative change of M-protein levels in serum or urine); overall survival is defined as the time from the first therapeutic procedure until death; time to progression is defined as the duration from the date of enrolment until the date of first documented evidence of progressive disease or relapse; duration of response is defined as the duration in months from the date of first evidence of confirmed response to the date of first documented evidence of progressive disease or relapse; quality of life is assessed by the questionnaires EORTC QLQ-C30 (Quality of life questionnaire) and EORTC EQ-5D (Euro Quality of life). Consolidation therapy lasts 4 cycles. Subjects will be treated with bortezomib 1.6 mg/m2 body surface intravenously once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35). At least 72 hours should relapse between consecutive doses of bortezomib. Therapy should be withheld at the onset of any Grade 3 nonhematological or Grade 4 hematological toxicities excluding neuropathy.
Ages Eligible for Study: | 61 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Germany | |
Recruiting | |
Eschweiler, Germany | |
Recruiting | |
Kaiserslautern, Germany | |
Recruiting | |
Bamberg, Germany | |
Active, not recruiting | |
Trier, Germany | |
Recruiting | |
Wiesbaden, Germany | |
Recruiting | |
Mutlangen, Germany | |
Recruiting | |
Regensburg, Germany | |
Recruiting | |
Karlsruhe, Germany | |
Recruiting | |
Leer, Germany | |
Recruiting | |
Lübeck, Germany | |
Recruiting | |
Hamburg, Germany | |
Recruiting | |
Stuttgart, Germany | |
Recruiting | |
Greifswald, Germany | |
Recruiting | |
Dortmund, Germany | |
Recruiting | |
Oldenburg, Germany | |
Recruiting | |
Kÿln N/A, Germany | |
Recruiting | |
Kiel, Germany | |
Recruiting | |
München, Germany | |
Recruiting | |
Berg, Germany | |
Recruiting | |
Dresden, Germany | |
Not yet recruiting | |
Tübingen, Germany | |
Recruiting | |
Berlin, Germany | |
Recruiting | |
Göttingen, Germany | |
Recruiting | |
Hamm, Germany | |
Recruiting | |
Jena, Germany | |
Recruiting | |
Würzburg, Germany | |
Recruiting | |
Kempten, Germany | |
Recruiting | |
Bremen, Germany | |
Recruiting | |
Duisburg, Germany | |
Recruiting | |
Frankfurt / Main, Germany | |
Recruiting | |
Halle, Germany | |
Recruiting | |
Erlangen, Germany | |
Recruiting | |
Münster, Germany | |
Recruiting | |
Goch, Germany | |
Recruiting | |
Nürnberg, Germany | |
Recruiting | |
Rostock, Germany | |
Recruiting | |
Villingen-Schwenningen, Germany | |
Recruiting | |
Magdeburg, Germany | |
Recruiting | |
Ulm, Germany |
Study Director: | Janssen-Cilag G.m.b.H. Clinical Trial | Janssen-Cilag G.m.b.H |
Responsible Party: | Janssen-Cilag G.m.b.H. ( Medical Advisor ) |
Study ID Numbers: | CR006127, 26866138MMY3013 |
Study First Received: | December 22, 2006 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00416208 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission |
Multiple Myeloma clinical trial bortezomib |
PS341 proteasome inhibitor consolidation therapy |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Protease Inhibitors Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Paraproteinemias |
Hemostatic Disorders Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |