Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT00416208
First received: December 22, 2006
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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
Drug: Bortezomib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag G.m.b.H:

Primary Outcome Measures:
  • The difference in event-free survival time will be compared between both arms [ Time Frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly [ Time Frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 154
Study Start Date: October 2006
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib
Bortezomib 1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
Drug: Bortezomib
1.6 mg/m2 i.v. d1 d8 d15 d22 for 4 cycles each of 35 days
No Intervention: Observation
Observational arm

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   61 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy
  • at least stable disease after stem cell transplantation
  • adequate hematological, hepatic and renal lab parameters
  • karnofsky status of 70 or more

Exclusion Criteria:

  • non-secretory multiple myeloma
  • previous treatment with bortezomib
  • allogenic stem cell transplantation
  • other co-existing malignancy beside basaliome
  • peripheral neuropathy
  • epilepsia
  • other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.)
  • history of allergic reactions to bortezomib or mannitol
  • expected life expectancy of less than 3 months
  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: NCT00416208

Locations
Germany
Bamberg, Germany
Berg, Germany
Berlin, Germany
Bremen, Germany
Dortmund, Germany
Dresden, Germany
Duisburg, Germany
Erlangen, Germany
Eschweiler, Germany
Frankfurt / Main, Germany
Freiburg, Germany
Goch, Germany
Greifswald, Germany
Göttingen, Germany
Halle, Germany
Hamburg, Germany
Hamm, Germany
Jena, Germany
Karlsruhe, Germany
Kempten, Germany
Kiel, Germany
Kÿln N/A, Germany
Lübeck, Germany
Magdeburg, Germany
Mutlangen, Germany
München, Germany
Münster, Germany
Nürnberg, Germany
Oldenburg, Germany
Regensburg, Germany
Rostock, Germany
Stuttgart, Germany
Trier, Germany
Ulm, Germany
Villingen-Schwenningen, Germany
Wiesbaden, Germany
Würzburg, Germany
Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
Study Director: Janssen-Cilag G.m.b.H. Clinical Trial Janssen-Cilag G.m.b.H
  More Information

No publications provided

Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT00416208     History of Changes
Other Study ID Numbers: CR006127, 26866138MMY3013
Study First Received: December 22, 2006
Last Updated: April 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by Janssen-Cilag G.m.b.H:
Multiple Myeloma
Clinical trial
Bortezomib
PS341
Proteasome inhibitor
Consolidation therapy

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
Proteasome Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014