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Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Primary Purpose

Multiple Myeloma, Myeloma, M-Protein

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Anthracyclines, Liposomes, Liposomal, Vincristine, Doxorubicin, Dexamethasone, Pegylated Liposomal Doxorubicin, DOXIL, drug resistant myeloma

Eligibility Criteria

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

Inclusion Criteria: Untreated multiple myeloma requiring treatment Total cumulative dose of prior doxorubicin can not exceed 240 mg/m2 Must have measurable disease Left Ventricular Ejection Fraction (LVEF) >= 50 % determined by Multiple Gated Acquisition Scan (MUGA) Karnofsky performance status of >= 60% Adequate bone marrow, liver and renal function Disease-free from prior malignancies >= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Exclusion Criteria: Life expectancy of >= 3 months Pregnant or breast feeding History of cardiac disease, with New York Heart Association Class II or greater, with congestive heart failure or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months Uncontrolled diabetes mellitus or systemic infection Nonsecretory myeloma, Monoclonal Gammopathy of Unknown Significance (MGUS) or smoldering myeloma Confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent Prior chemotherapy to treat Multiple Myeloma Prior radiotherapy to an area greater than 1/3 of the skeleton Prior local radiotherapy within 1 week of treatment Any investigational agent within 30 days of the first dose of treatment Prior single agent dexamethasone (or another corticosteroid) to treat Multiple Myeloma.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs VAD.

    Secondary Outcome Measures

    To evaluate and compare the clinical benefit of VDD vs VAD for the following measures: Hospitalization, Documented sepsis,Antibiotic use, Grade 3 or 4 neutropenia or neutropenic fever

    Full Information

    First Posted
    June 23, 2006
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00344422
    Brief Title
    Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
    Official Title
    A Multi-Center Randomized Study of Vincristine, Doxil and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).
    Detailed Description
    This is a randomized, open label study comparing the efficacy, clinical benefit, toxicity and safety of the combination of Vincristine, DOXIL® (doxorubicin HCl liposome injection), and Dexamethasone (VDD) to the standard regimen of Vincristine, Doxorubicin and Dexamethasone (VAD) in patients with newly diagnosed multiple myeloma. Approximately 200 patients with newly diagnosed multiple myeloma will be randomized to receive either VDD or VAD. This study will determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs. VAD. This study will also evaluate and compare the clinical benefit of VDD vs. VAD for the following measures: Hospitalization; Documented sepsis; Antibiotic use; Grade 3 or 4 neutropenia or neutropenic fever. VDD: Vincristine 1.4 mg/m2 IV on Day 1; Doxil® 40 mg/m2 IV on Day 1; Dexamethasone 40 mg/day oral Days 1-4; VAD: Vincristine 0.4 mg/day continuous infusion Days 1-4; Doxorubicin 9.0 mg/m2/day continuous infusion Days 1-4; Dexamethasone 40 mg/day orally on Days 1-4; Every 28 days for 4 cycles

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma, Myeloma, M-Protein, Myeloma Proteins
    Keywords
    Anthracyclines, Liposomes, Liposomal, Vincristine, Doxorubicin, Dexamethasone, Pegylated Liposomal Doxorubicin, DOXIL, drug resistant myeloma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    198 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Vincristine, DOXIL (doxorubicin HCl liposomal injection), and Dexamethasone (VDD) vs. Vincristine, Doxorubicin and Dexamethasone (VAD)
    Primary Outcome Measure Information:
    Title
    To determine and compare the objective response rate (the percentage of patients who attain an Objective Status of Complete Remission, Remission or Partial Remission) for patients receiving VDD vs VAD.
    Secondary Outcome Measure Information:
    Title
    To evaluate and compare the clinical benefit of VDD vs VAD for the following measures: Hospitalization, Documented sepsis,Antibiotic use, Grade 3 or 4 neutropenia or neutropenic fever

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Untreated multiple myeloma requiring treatment Total cumulative dose of prior doxorubicin can not exceed 240 mg/m2 Must have measurable disease Left Ventricular Ejection Fraction (LVEF) >= 50 % determined by Multiple Gated Acquisition Scan (MUGA) Karnofsky performance status of >= 60% Adequate bone marrow, liver and renal function Disease-free from prior malignancies >= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Exclusion Criteria: Life expectancy of >= 3 months Pregnant or breast feeding History of cardiac disease, with New York Heart Association Class II or greater, with congestive heart failure or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months Uncontrolled diabetes mellitus or systemic infection Nonsecretory myeloma, Monoclonal Gammopathy of Unknown Significance (MGUS) or smoldering myeloma Confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent Prior chemotherapy to treat Multiple Myeloma Prior radiotherapy to an area greater than 1/3 of the skeleton Prior local radiotherapy within 1 week of treatment Any investigational agent within 30 days of the first dose of treatment Prior single agent dexamethasone (or another corticosteroid) to treat Multiple Myeloma.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16404741
    Citation
    Rifkin RM, Gregory SA, Mohrbacher A, Hussein MA. Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma: a Phase III multicenter randomized trial. Cancer. 2006 Feb 15;106(4):848-58. doi: 10.1002/cncr.21662.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=479&filename=CR002434_CSR.pdf
    Description
    A Multi-Center Randomized Study of Vincristine, DOXIL and Dexamethasone vs. Vincristine Doxorubicin, and Dexamethasone in Patients with Multiple Myeloma

    Learn more about this trial

    Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

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