Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

Last updated: September 28, 2015
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Lymphoproliferative Disorders

Leukemia

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT00103506
CR004117
2004-001842-34
DOXILMMY3001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with multiple myeloma who have received at least 1 prior therapy and who haveeither responded and later had progressive disease or have progressed during theirfirst therapy (primary refractory) are eligible for the study

  • Patients who may have received prior doxorubicin but not more than a cumulative doseof 240 milligram per meter square (mg/m^2) doxorubicin, DOXIL, or the equivalentamount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mgepirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)

  • Must have normal cardiac function, as evidenced by a left LVEF within institutionalnormal limits.

Exclusion

Exclusion Criteria:

  • History of treatment with VELCADE or progressive disease while receiving ananthracycline-containing regimen

  • No change in disease status during initial therapy

  • No treatment for malignancy within past 5 yrs (other than multiple myeloma) orprogressive disease while receiving anthracycline-containing regimen

  • Non-secretory disease

  • Myocardial infarct within past 6 months

  • No major surgery in past 30 days.

Study Design

Total Participants: 646
Study Start date:
December 01, 2004
Estimated Completion Date:
June 30, 2014

Study Description

This is a randomized (study drug assigned by chance), parallel-group, open-label (all involved people know the identity of the intervention), multicenter study in 18 countries. A total of 646 patients with multiple myeloma whose disease has progressed after an initial response to at least 1 line of prior therapy or was refractory to initial treatment will be enrolled. The primary endpoint is time to progression (the interval between the date of randomization and the date of disease progression); secondary endpoints are overall survival (the interval between the date of randomization and the patient's death from any cause), response rate (the proportion of patients in the evaluable population who achieved a complete or partial response), and safety. Other study endpoints include patient reported outcomes and exploratory pharmacogenics (to identify genetic markers of response). Patients are assessed for efficacy and safety every 3 weeks until disease progression is documented or for up to 42 weeks from the start of the first dose of study drug. Patients, who do not progress after the 42-week period, are assessed every 6 weeks until disease progression is documented. Efficacy evaluations includes: serum protein electrophoresis, 24-hour urine collection for protein electrophoresis, skeletal survey (plain films), bone marrow biopsy and aspirate, clinical or radiologic assessment of plasmacytomas, and serum calcium. Responses and progressions are assessed objectively by a computer algorithm based on the EBMT criteria. Safety evaluations include adverse event reports, changes in clinical laboratory findings, and tests for cardiac function (multiple gated acquisition scan/echocardiogram and electrocardiogram). Group A: VELCADE monotherapy: VELCADE 1.3 milligram per meter square (mg/m^2) to be administered by i.v. bolus on Days 1, 4, 8, and 11 of each 21-day cycle. Group B: DOXIL/VELCADE combination: treated with VELCADE at the same dose and schedule as specified in Group A. DOXIL/CAELYX 30 mg/m^2 by intravenous infusion given on Day 4 of every 21-day cycle following the administration of VELCADE.

Connect with a study center

  • Buenos Aires,
    Argentina

    Site Not Available

  • Ciudad De Buenos Aires,
    Argentina

    Site Not Available

  • La Plata,
    Argentina

    Site Not Available

  • Mendoza,
    Argentina

    Site Not Available

  • Adelaide,
    Australia

    Site Not Available

  • Darlinghurst,
    Australia

    Site Not Available

  • Melbourne,
    Australia

    Site Not Available

  • empty

    Parkville,
    Australia

    Site Not Available

  • Perth,
    Australia

    Site Not Available

  • Sydney,
    Australia

    Site Not Available

  • Graz,
    Austria

    Site Not Available

  • Innsbruck,
    Austria

    Site Not Available

  • Salzburg,
    Austria

    Site Not Available

  • Wels N/A,
    Austria

    Site Not Available

  • Wien,
    Austria

    Site Not Available

  • Brussel,
    Belgium

    Site Not Available

  • Gent,
    Belgium

    Site Not Available

  • Leuven,
    Belgium

    Site Not Available

  • Mont-Godinne,
    Belgium

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Hamilton, Ontario
    Canada

    Site Not Available

  • Ottawa, Ontario
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • N/a N/a,
    Canada

    Site Not Available

  • Quebec,
    Canada

    Site Not Available

  • Brno,
    Czech Republic

    Site Not Available

  • Olomouc,
    Czech Republic

    Site Not Available

  • empty

    Olomouc N/A,
    Czech Republic

    Site Not Available

  • empty

    Praha,
    Czech Republic

    Site Not Available

  • Praha 2 N/A,
    Czech Republic

    Site Not Available

  • empty

    Angers,
    France

    Site Not Available

  • Angers Cedex 1 N/A,
    France

    Site Not Available

  • Bobigny,
    France

    Site Not Available

  • Creteil N/A,
    France

    Site Not Available

  • Lille Cedex N/A,
    France

    Site Not Available

  • empty

    Lyon,
    France

    Site Not Available

  • Nantes N/A,
    France

    Site Not Available

  • Pierre Benite,
    France

    Site Not Available

  • Toulouse,
    France

    Site Not Available

  • Tours,
    France

    Site Not Available

  • Vandoeuvre Les Nancy,
    France

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Jerusalem,
    Israel

    Site Not Available

  • Petach Tikva,
    Israel

    Site Not Available

  • Ramat Gan,
    Israel

    Site Not Available

  • Rehovot,
    Israel

    Site Not Available

  • Tel Aviv,
    Israel

    Site Not Available

  • Amersfoort,
    Netherlands

    Site Not Available

  • Amsterdam,
    Netherlands

    Site Not Available

  • Amsterdam Zuidoost,
    Netherlands

    Site Not Available

  • Delft,
    Netherlands

    Site Not Available

  • Den Haag,
    Netherlands

    Site Not Available

  • Groningen,
    Netherlands

    Site Not Available

  • Nieuwegein,
    Netherlands

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  • Nijmegen,
    Netherlands

    Site Not Available

  • Rotterdam,
    Netherlands

    Site Not Available

  • Utrecht,
    Netherlands

    Site Not Available

  • Bialystok,
    Poland

    Site Not Available

  • Gdansk,
    Poland

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  • Lodz,
    Poland

    Site Not Available

  • Lublin,
    Poland

    Site Not Available

  • Warszawa,
    Poland

    Site Not Available

  • Wroclaw,
    Poland

    Site Not Available

  • Coimbra,
    Portugal

    Site Not Available

  • Lisboa,
    Portugal

    Site Not Available

  • Porto N/A,
    Portugal

    Site Not Available

  • Arkhangelsk,
    Russian Federation

    Site Not Available

  • Ekaterinburg,
    Russian Federation

    Site Not Available

  • Izhevsk,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Moscow N/A,
    Russian Federation

    Site Not Available

  • Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • Novosibirsk,
    Russian Federation

    Site Not Available

  • Obninsk,
    Russian Federation

    Site Not Available

  • empty

    Obninsk N/A,
    Russian Federation

    Site Not Available

  • empty

    St,
    Russian Federation

    Site Not Available

  • St. Petersburg,
    Russian Federation

    Site Not Available

  • Singapore,
    Singapore

    Site Not Available

  • Bloemfontein N/A,
    South Africa

    Site Not Available

  • Cape Town,
    South Africa

    Site Not Available

  • Johannesburg,
    South Africa

    Site Not Available

  • Parktown,
    South Africa

    Site Not Available

  • Pretoria Gauteng,
    South Africa

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Madrid,
    Spain

    Site Not Available

  • Salamanca,
    Spain

    Site Not Available

  • Bath,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Alabaster, Alabama
    United States

    Site Not Available

  • Surprise, Arizona
    United States

    Site Not Available

  • Berkeley, California
    United States

    Site Not Available

  • Loma Linda, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Sacramento, California
    United States

    Site Not Available

  • Norwalk, Connecticut
    United States

    Site Not Available

  • Stamford, Connecticut
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Stuart, Florida
    United States

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  • West Palm Beach, Florida
    United States

    Site Not Available

  • Altanta, Georgia
    United States

    Site Not Available

  • empty

    Tucker, Georgia
    United States

    Site Not Available

  • Boise, Idaho
    United States

    Site Not Available

  • Indianapolis, Indiana
    United States

    Site Not Available

  • Lexington, Kentucky
    United States

    Site Not Available

  • Metairie, Louisiana
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

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  • Hackensack, New Jersey
    United States

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  • Chapel Hill, North Carolina
    United States

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  • Charlotte, North Carolina
    United States

    Site Not Available

  • Durham, North Carolina
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • N Charleston, South Carolina
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

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