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Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma

Primary Purpose

Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bortezomib
cyclophosphamide
dexamethasone
laboratory biomarker analysis
quality-of-life assessment
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have a confirmed diagnosis of symptomatic myeloma in accordance with International Myeloma Working group (IMWG) criteria

    • Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
    • Symptomatic disease, i.e., end-organ damage due to multiple myeloma (MM) including at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
  • Absolute neutrophil count (ANC) >= 1000 cells/mm^3 (without use of growth factors)
  • Platelets >= 50,000 cells/mm^3
  • Direct bilirubin =< 1.5 X upper limit of normal (ULN); elevated bilirubin is permissible if patient has a known history of elevated bilirubin due to Gilbert's or if elevated bilirubin is due to hemolysis
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 X ULN
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior treatment with > 1 cycle of any plasma cell myeloma (PCM) induction regimen (maximum 6 weeks of prior treatment)

    • Prior radiation therapy is allowed
    • Prior treatment for other cancers is allowed as long as patient meets criteria for adequate hematopoietic and organ function and is not actively on chemotherapy for another cancer
  • Grade >= 2 peripheral neuropathy
  • Second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy for breast or prostate cancer is allowed
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cyclophosphamide, dexamethasone or other agents used in this study
  • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (bortezomib, cyclophosphamide, dexamethasone)

    Arm Description

    Patients receive bortezomib SC or IV over 3-5 seconds on days 1, 8, and 15; cyclophosphamide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Overall Response rate in accordance with the IMWG Uniform Response criteria
    The number of people with any response as defined by the IMWG criteria
    Incidence of toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4

    Secondary Outcome Measures

    Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
    Changes in quality of life at baseline to the end of treatment estimated by means with confidence intervals. Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.
    Changes in functional status
    Changes in functional status at baseline to the end of treatment estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).
    Overall Survival
    The number of people alive after 24 weeks on the study
    Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
    Average changes in quality of life at baseline estimated by means with confidence intervals.Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.
    Changes in functional status
    Changes in functional status at baseline to the second course 2 of therapy estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).

    Full Information

    First Posted
    March 6, 2014
    Last Updated
    April 23, 2015
    Sponsor
    Case Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02082405
    Brief Title
    Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma
    Official Title
    A Phase II Trial of Weekly Bortezomib and Dexamethasone With Oral Metronomic Cyclophosphamide in Elderly Patients With Plasma Cell Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding unavailable
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This phase II trial studies the side effects and how well lower doses of bortezomib, dexamethasone, and cyclophosphamide work in treating older patients with multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide daily may kill more cancer cells. Giving bortezomib, cyclophosphamide, and dexamethasone may be an effective treatment for multiple myeloma.
    Detailed Description
    PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) and toxicity rate of therapy with weekly bortezomib combined with oral metronomic cyclophosphamide and low-dose dexamethasone. SECONDARY OBJECTIVES: I. To determine overall survival. II. To describe the association between disease status, treatment response, treatment toxicity, quality of life, functional status, risk for development of frailty, and inflammatory cytokine levels. OUTLINE: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) over 3-5 seconds on days 1, 8, and 15; cyclophosphamide orally (PO) once daily (QD) on days 1-21; and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III 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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (bortezomib, cyclophosphamide, dexamethasone)
    Arm Type
    Experimental
    Arm Description
    Patients receive bortezomib SC or IV over 3-5 seconds on days 1, 8, and 15; cyclophosphamide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    bortezomib
    Other Intervention Name(s)
    LDP 341, MLN341, VELCADE
    Intervention Description
    Given SC or IV
    Intervention Type
    Drug
    Intervention Name(s)
    cyclophosphamide
    Other Intervention Name(s)
    CPM, CTX, Cytoxan, Endoxan, Endoxana
    Intervention Description
    Given PO
    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone
    Other Intervention Name(s)
    Aeroseb-Dex, Decaderm, Decadron, DM, DXM
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Description
    Optional correlative studies
    Intervention Type
    Other
    Intervention Name(s)
    quality-of-life assessment
    Other Intervention Name(s)
    quality of life assessment
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Overall Response rate in accordance with the IMWG Uniform Response criteria
    Description
    The number of people with any response as defined by the IMWG criteria
    Time Frame
    Up to 7 months
    Title
    Incidence of toxicities according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4
    Time Frame
    Up to 7 months
    Secondary Outcome Measure Information:
    Title
    Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
    Description
    Changes in quality of life at baseline to the end of treatment estimated by means with confidence intervals. Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.
    Time Frame
    Up to 24 weeks
    Title
    Changes in functional status
    Description
    Changes in functional status at baseline to the end of treatment estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).
    Time Frame
    Up to 24 weeks
    Title
    Overall Survival
    Description
    The number of people alive after 24 weeks on the study
    Time Frame
    24 Weeks
    Title
    Changes in quality of life as assessed by the Functional Assessment of Cancer Therapy-General
    Description
    Average changes in quality of life at baseline estimated by means with confidence intervals.Quality of life will be assessed using the 34 item general functional assessment of cancer therapy (FACT-G) questionnaire.
    Time Frame
    After 6 weeks (2 courses) of treatment
    Title
    Changes in functional status
    Description
    Changes in functional status at baseline to the second course 2 of therapy estimated by means with confidence intervals. Functional status will be assessed by scoring the thirteen item Vulnerable Elders Survey (VES-13).
    Time Frame
    After 6 weeks (2 courses) of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have a confirmed diagnosis of symptomatic myeloma in accordance with International Myeloma Working group (IMWG) criteria Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma Symptomatic disease, i.e., end-organ damage due to multiple myeloma (MM) including at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction Absolute neutrophil count (ANC) >= 1000 cells/mm^3 (without use of growth factors) Platelets >= 50,000 cells/mm^3 Direct bilirubin =< 1.5 X upper limit of normal (ULN); elevated bilirubin is permissible if patient has a known history of elevated bilirubin due to Gilbert's or if elevated bilirubin is due to hemolysis Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 X ULN Subjects must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Prior treatment with > 1 cycle of any plasma cell myeloma (PCM) induction regimen (maximum 6 weeks of prior treatment) Prior radiation therapy is allowed Prior treatment for other cancers is allowed as long as patient meets criteria for adequate hematopoietic and organ function and is not actively on chemotherapy for another cancer Grade >= 2 peripheral neuropathy Second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy for breast or prostate cancer is allowed Patients may not be receiving any other investigational agents History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cyclophosphamide, dexamethasone or other agents used in this study Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erica Campagnaro
    Organizational Affiliation
    Case Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma

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