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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT00416273
First received: December 22, 2006
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Drug: No intervention
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 <= 60 Year Old Patients With Multiple Myeloma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Response rates [ Time Frame: Up to Week 25 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    Time interval in months between the date of randomization and the participant's death from any cause.

  • 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 ] [ Designated as safety issue: No ]
    Time to progression is time interval in months until progression of disease, censoring for death or drop-out without progression.

  • Duration of response [ Time Frame: Up to Week 25 ] [ Designated as safety issue: No ]
    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.

  • Number of patients with toxicities over the treatment period [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    Toxicities will be assessed according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Number of the patients with skeletal related event (SRE) [ Time Frame: Up to 30-60 months ] [ Designated as safety issue: Yes ]
    Pathological fracture, spinal cord compression, radiotherapy of a bone lesion, surgical therapy of a bone lesion will be considered as skeletal related events.

  • Time interval from the day of the transplantation up to the occurrence of the first SRE [ Time Frame: Up to 30-60 months ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 217
Study Start Date: December 2006
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00416273

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
Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H
  More Information

No publications provided

Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT00416273     History of Changes
Other Study ID Numbers: CR006124, 26866138MMY3012, 2005-004948-31
Study First Received: December 22, 2006
Last Updated: March 16, 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
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 20, 2014