Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma

March 4, 2015 updated by: Janssen-Cilag G.m.b.H

Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag G.m.b.H

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 22, 2006

First Posted (Estimate)

December 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006127
  • 26866138MMY3013 (Other Identifier: Janssen-Cilag G.m.b.H, Germany)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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