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NCT Number: NCT00416273

A Study of Bortezomib as Consolidation Therapy in 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Augsburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

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.

No intervention

Drug

Participants in the observation group will be observed and will not receive any consolidation therapy.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Time interval from the day of the transplantation up to the occurrence of the first SRE

    Time frame: Up to 30-60 months

  10. 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.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag G.m.b.H

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Dec 27, 2006
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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