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A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Doxil
Thalidomide
Dexamethasone
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with active, symptomatic multiple myeloma without prior chemotherapy: Durie-Salmon Stage II-III A/B Stage I patients with at least 2 of the poor prognostic indicators may be eligible. Patients with plasma cell leukemia Non-secretory multiple myeloma patients are eligible Patients between the ages of 18 and 75 years old Female Patients of child bearing age (up to age 50) who are not pregnant and agree to use two adequate birth control methods during the study and at least six months after treatment unless patient has undergone hysterectomy or has been in menopause for 2 years. Patients with Southwest Oncology Group (SWOG) performance status of 3 or better Patients who have received prior lower dose Dexamethasone Therapy (ie. 4 mg QID) as adjunct to radiation therapy for cord compression may be eligible All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater than or equal to 50% within 42 days prior to registration Must be able to understand English. Must be willing and eligible to sign up for the STEPS program Exclusion Criteria: Nursing mothers or women who are pregnant Patients with a history of hypersensitivity reaction to doxorubicin or agents in Doxil® Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years. History of mediastinal radiation for any reason History of receiving prior anthracyclines Patients with uncontrolled medical problems such as diabetes mellitus, cardiac, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma Myocardial infarction within 6 months of enrollment in the study. Major surgery within 4 weeks of enrollment. Patients previously treated or receiving other treatment for multiple myeloma other than lower doses dexamethasone as adjunct to radiotherapy Pre-existing peripheral neuropathy Patients with previously diagnosed malabsorption syndromes or anatomical abnormalities of the gastrointestinal tract that result in malabsorption syndromes. Patients with a history of cardiac disease, defined as New York Heart Association Class II or greater, or clinical evidence of congestive heart failure. Patients with psychiatric or central nervous systems disorders interfering with compliance of orally administered medication. Patients currently receiving anticoagulant therapy for venous thromboembolic episode or other hypercoagulable states. Patients who are unable to understand the English language.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Doxil, Thalidomide, Dexamethasone

    Outcomes

    Primary Outcome Measures

    Overall Response Rate
    Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.

    Secondary Outcome Measures

    Toxicity
    Count of Participants with adverse events.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 5, 2017
    Sponsor
    University of Kansas Medical Center
    Collaborators
    Ortho Biotech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00222105
    Brief Title
    A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
    Official Title
    Doxil® (Pegylated Liposomal Doxorubicin), Dexamethasone Plus Thalidomide (Ddt) in Previously Untreated Multiple Myeloma: A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Kansas Medical Center
    Collaborators
    Ortho Biotech, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant.
    Detailed Description
    Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects. This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Doxil, Thalidomide, Dexamethasone
    Intervention Type
    Drug
    Intervention Name(s)
    Doxil
    Other Intervention Name(s)
    pegylated liposomal doxorubicin
    Intervention Description
    Doxil 40 mg/m2 IV day 1
    Intervention Type
    Drug
    Intervention Name(s)
    Thalidomide
    Other Intervention Name(s)
    thalidomid
    Intervention Description
    50-100 mg day 1-28
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    decadron
    Intervention Description
    Dexamethasone 40 mg day 1-4 and 15-18
    Primary Outcome Measure Information:
    Title
    Overall Response Rate
    Description
    Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.
    Time Frame
    At End of Cycle 1, 28 Days
    Secondary Outcome Measure Information:
    Title
    Toxicity
    Description
    Count of Participants with adverse events.
    Time Frame
    End of study, up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with active, symptomatic multiple myeloma without prior chemotherapy: Durie-Salmon Stage II-III A/B Stage I patients with at least 2 of the poor prognostic indicators may be eligible. Patients with plasma cell leukemia Non-secretory multiple myeloma patients are eligible Patients between the ages of 18 and 75 years old Female Patients of child bearing age (up to age 50) who are not pregnant and agree to use two adequate birth control methods during the study and at least six months after treatment unless patient has undergone hysterectomy or has been in menopause for 2 years. Patients with Southwest Oncology Group (SWOG) performance status of 3 or better Patients who have received prior lower dose Dexamethasone Therapy (ie. 4 mg QID) as adjunct to radiation therapy for cord compression may be eligible All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater than or equal to 50% within 42 days prior to registration Must be able to understand English. Must be willing and eligible to sign up for the STEPS program Exclusion Criteria: Nursing mothers or women who are pregnant Patients with a history of hypersensitivity reaction to doxorubicin or agents in Doxil® Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years. History of mediastinal radiation for any reason History of receiving prior anthracyclines Patients with uncontrolled medical problems such as diabetes mellitus, cardiac, pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma Myocardial infarction within 6 months of enrollment in the study. Major surgery within 4 weeks of enrollment. Patients previously treated or receiving other treatment for multiple myeloma other than lower doses dexamethasone as adjunct to radiotherapy Pre-existing peripheral neuropathy Patients with previously diagnosed malabsorption syndromes or anatomical abnormalities of the gastrointestinal tract that result in malabsorption syndromes. Patients with a history of cardiac disease, defined as New York Heart Association Class II or greater, or clinical evidence of congestive heart failure. Patients with psychiatric or central nervous systems disorders interfering with compliance of orally administered medication. Patients currently receiving anticoagulant therapy for venous thromboembolic episode or other hypercoagulable states. Patients who are unable to understand the English language.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Delva Deauna-Limayo, MD
    Organizational Affiliation
    University of Kansas Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

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