A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma

March 5, 2015 updated by: Janssen-Cilag G.m.b.H

Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma

The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.

Study Type

Interventional

Enrollment (Actual)

217

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
      • Augsburg, Germany
      • Bamberg, Germany
      • Berg, Germany
      • Berlin, Germany
      • Bremen, 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
      • Hannover, Germany
      • Homburg, Germany
      • Jena, Germany
      • Karlsruhe, Germany
      • Kempten, Germany
      • Kiel, Germany
      • Köln, Germany
      • Magdeburg, Germany
      • Mainz, Germany
      • Mutlangen, Germany
      • München, Germany
      • Münster, Germany
      • Nürnberg, Germany
      • Oldenburg, Germany
      • Regensburg, Germany
      • Rostock, Germany
      • Stuttgart, 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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
  • Women must be postmenopausal or using safe contraception methods
  • Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges

Exclusion Criteria:

  • No asecretory multiple myeloma
  • History of allergic reactions to bortezomib or mannitol
  • Expected life expectancy of less than 3 months
  • No other malignant disease beside basalioma either existing or history of
  • No history of severe cardio-pulmonary disease
  • Seizures

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: Treatment group
Participants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.
Drug: Bortezomib
Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.
Experimental: Observation group
Participants in the observation group will not receive any consolidation therapy.
Drug: No intervention
Participants in the observation group will be observed and will not receive any consolidation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with event-free survival (PFS)
Time Frame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with event free survival (EFS)
Time Frame: From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
Response rates
Time Frame: Up to Week 25
Response will be determined according to EBMT (European Group for Blood and Marrow Transplantation) criteria; VGPR (very good partial response) will be added as an additional response criteria. VGPR is measured as at least 90 percents reduction of the monoclonal protein in the serum over at least 6 weeks.
Up to Week 25
Overall survival
Time Frame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled
Time interval in months between the date of randomization and the participant's death from any cause.
From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled
Time to progression
Time Frame: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled
Time to progression is time interval in months until progression of disease, censoring for death or drop-out without progression.
From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled
Duration of response
Time Frame: Up to Week 25
Duration of the response, measured from the day on which a response (at least minimal response) was documented for the first time after the start of the therapy, up until the day of the documentation of a progression/recurrence requiring therapy.
Up to Week 25
Number of patients with toxicities over the treatment period
Time Frame: Up to Week 24
Toxicities will be assessed according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.
Up to Week 24
Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)
Time Frame: Baseline (Day 1), Enpoint (30-60 months)
EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening.
Baseline (Day 1), Enpoint (30-60 months)
Number of the patients with skeletal related event (SRE)
Time Frame: Up to 30-60 months
Pathological fracture, spinal cord compression, radiotherapy of a bone lesion, surgical therapy of a bone lesion will be considered as skeletal related events.
Up to 30-60 months
Time interval from the day of the transplantation up to the occurrence of the first SRE
Time Frame: Up to 30-60 months
Up to 30-60 months
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to end point (30-60 months)
Time Frame: Baseline (Day 1) and end point (30-60 months)
Change from Baseline to end point (30-60 months) in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
Baseline (Day 1) and end point (30-60 months)

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

December 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 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006124
  • 26866138MMY3012 (Other Identifier: Janssen-Cilag G.m.b.H, Germany)
  • 2005-004948-31 (EudraCT Number)

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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