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A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone
Sponsored by
Janssen-Ortho Inc., Canada
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, response rate, peripheral stem cell transplant, safety, tolerability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients with newly diagnosed multiple myeloma (MM) requiring therapy for whom stem cell transplantation is considered appropriate
  • Normal left ventricular ejection fraction
  • Able to give voluntary written informed consent
  • Female patients agree to use acceptable method for contraception

Exclusion Criteria:

  • Diagnosis of smoldering multiple myeloma (asymptomatic MM with absence of lytic bone lesions)
  • Renal insufficiency related to the monoclonal protein
  • Diagnosis of Waldenström's disease
  • Previous treatment for MM (excepting emergency use of a short course dexamethasone, radiation received > 30 days before study enrolment, plasmapheresis for treatment of clinically significant hyperviscosity syndrome > 30 days before trial enrolment)
  • Major surgery within 30 days before entry
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher within 14 days of trial enrolment
  • Uncontrolled or severe cardiovascular disease (including myocardial infarction within 6 months prior to enrollment
  • NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, cardiac amyloidosis, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities)
  • Other malignancy within the past 5 years prior to enrolment (except for non-active basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or Stage 1 carcinoma of the cervix
  • Known HIV seropositivity or active hepatitis A, B, or C infection
  • Use of any investigational drug within 30 days prior to enrolment in the trial
  • Medical or psychiatric condition that could interfere with trial participation
  • History of hypersensitivity or allergic reaction attributable to compounds containing boron, mannitol or doxorubicin.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary endpoint was complete response (CR) and near complete response rate (nCR) post induction therapy (i.e. 4 cycles of therapy). Each cycle consisted of 21 days.

    Secondary Outcome Measures

    The secondary endpoints included time to best response, assessment of peripheral blood stem cells harvesting ( 3 weeks post cycle 4 day 21) and engraftment (within 4 weeks of mobilization), CR post-engraftment, QoL and safety (every cycle).

    Full Information

    First Posted
    November 19, 2007
    Last Updated
    June 7, 2011
    Sponsor
    Janssen-Ortho Inc., Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00561743
    Brief Title
    A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients
    Official Title
    A Phase II Study to Assess the Safety and Efficacy of DBd Combination Therapy (DOXIL/CAELYX) [Doxorubicin HCL Liposome Injection], VELCADE [Bortezomib] and Dexamethasone) for Previously Untreated Multiple Myeloma Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen-Ortho Inc., Canada

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether doxorubicin HCL liposome injection, bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of action.
    Detailed Description
    This was a single-arm, open-label, Phase II multi-centre study in Canada only. A total of 50 newly diagnosed multiple myeloma patients who were eligible for stem cell transplant were targeted for recruitment to this study. Combination doxorubicin HCL liposome injection, bortezomib and dexamethasone induction therapy was given for 4 cycles in preparation for stem cell collection and transplant. As remission status after induction and prior to the first or second auto-transplant has been shown to be the major determinant of both event free and overall survival in multiple myeloma patients, the goal has been to improve response rates through the use of various combinational approaches. As such, the objective of the present study was to test the hypothesis that treatment with this regimen could result in a higher complete + near complete response rate (CR + nCR) prior to stem cell transplant, than obtained with current regimens, and then to confirm the response rate post-transplant. Safety was evaluated using adverse event reportings, clinical laboratory tests and tests for cardiac function (multiple-gated acquisition scan/echocardiogram and electrocardiogram). Four 21-day cycles of combination induction therapy consisting of 1.3 mg/m2 bortezomib (given i.v. Days 1, 4, 8, 11) + 30 mg/m2 Doxil/Caelyx (given i.v. Day 4) + 40 mg Dex (given po Days 1-4, 8-11, 15-18 Cycle 1 only; Days 1-4 Cycles 2-4).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Multiple myeloma, response rate, peripheral stem cell transplant, safety, tolerability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone
    Primary Outcome Measure Information:
    Title
    The primary endpoint was complete response (CR) and near complete response rate (nCR) post induction therapy (i.e. 4 cycles of therapy). Each cycle consisted of 21 days.
    Secondary Outcome Measure Information:
    Title
    The secondary endpoints included time to best response, assessment of peripheral blood stem cells harvesting ( 3 weeks post cycle 4 day 21) and engraftment (within 4 weeks of mobilization), CR post-engraftment, QoL and safety (every cycle).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients with newly diagnosed multiple myeloma (MM) requiring therapy for whom stem cell transplantation is considered appropriate Normal left ventricular ejection fraction Able to give voluntary written informed consent Female patients agree to use acceptable method for contraception Exclusion Criteria: Diagnosis of smoldering multiple myeloma (asymptomatic MM with absence of lytic bone lesions) Renal insufficiency related to the monoclonal protein Diagnosis of Waldenström's disease Previous treatment for MM (excepting emergency use of a short course dexamethasone, radiation received > 30 days before study enrolment, plasmapheresis for treatment of clinically significant hyperviscosity syndrome > 30 days before trial enrolment) Major surgery within 30 days before entry Peripheral neuropathy or neuropathic pain Grade 2 or higher within 14 days of trial enrolment Uncontrolled or severe cardiovascular disease (including myocardial infarction within 6 months prior to enrollment NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, cardiac amyloidosis, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities) Other malignancy within the past 5 years prior to enrolment (except for non-active basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or Stage 1 carcinoma of the cervix Known HIV seropositivity or active hepatitis A, B, or C infection Use of any investigational drug within 30 days prior to enrolment in the trial Medical or psychiatric condition that could interfere with trial participation History of hypersensitivity or allergic reaction attributable to compounds containing boron, mannitol or doxorubicin.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Ortho Inc. Clinical Trial
    Organizational Affiliation
    Janssen-Ortho Inc., Canada
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients

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