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Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCIO-469
SCIO-469 and bortezomib
Sponsored by
Scios, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, SCIO-469, p38 MAP kinase, myeloma, bone marrow

Eligibility Criteria

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

Inclusion Criteria: Life expectancy more than three months diagnosed with multiple myeloma (MM) relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy Karnofsky performance status = 60 no electrocardiographic evidence of acute ischemia or new conduction system abnormalities no history of myocardial infarction within last 6 months serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN) total serum bilirubin = 2X ULN Calculated or measured creatinine clearance >30 mL/min platelet count = 30 x 10(9)/L hemoglobin concentration = 8 g/dL white blood cell count = 2.0 x 10(9)/L Exclusion Criteria: Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes) major surgery within four weeks of enrollment severe elevated serum calcium heart failure receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment known allergies to agents used in bortezomib (e.g., boron or mannitol) poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    001

    002

    Arm Description

    SCIO-469 two 30-mg capsules three times daily

    SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period

    Outcomes

    Primary Outcome Measures

    Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.

    Secondary Outcome Measures

    Time to first response, time to best response, and percentage of patients with disease progression were assessed.
    Size and number of lytic bone lesions were summarized.
    Quality of life and pain was assessed.
    Performance status was evaluated.
    Bone disease was monitored by assessing various markers.

    Full Information

    First Posted
    July 14, 2004
    Last Updated
    October 15, 2010
    Sponsor
    Scios, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00087867
    Brief Title
    Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
    Official Title
    An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Scios, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.
    Detailed Description
    The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Multiple Myeloma, SCIO-469, p38 MAP kinase, myeloma, bone marrow

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    SCIO-469 two 30-mg capsules three times daily
    Arm Title
    002
    Arm Type
    Other
    Arm Description
    SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period
    Intervention Type
    Drug
    Intervention Name(s)
    SCIO-469
    Intervention Description
    two 30-mg capsules three times daily
    Intervention Type
    Drug
    Intervention Name(s)
    SCIO-469 and bortezomib
    Intervention Description
    In addition to SCIO-469, patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period
    Primary Outcome Measure Information:
    Title
    Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
    Time Frame
    Day 73
    Secondary Outcome Measure Information:
    Title
    Time to first response, time to best response, and percentage of patients with disease progression were assessed.
    Time Frame
    Days 1, 15, 30, 52, and 73
    Title
    Size and number of lytic bone lesions were summarized.
    Time Frame
    screening and Day 73
    Title
    Quality of life and pain was assessed.
    Time Frame
    Days 1, 15,30,52,73
    Title
    Performance status was evaluated.
    Time Frame
    Screening, Days 1, 30, 73
    Title
    Bone disease was monitored by assessing various markers.
    Time Frame
    Days 1, 15, 30, 52, 73

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Life expectancy more than three months diagnosed with multiple myeloma (MM) relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy Karnofsky performance status = 60 no electrocardiographic evidence of acute ischemia or new conduction system abnormalities no history of myocardial infarction within last 6 months serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN) total serum bilirubin = 2X ULN Calculated or measured creatinine clearance >30 mL/min platelet count = 30 x 10(9)/L hemoglobin concentration = 8 g/dL white blood cell count = 2.0 x 10(9)/L Exclusion Criteria: Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes) major surgery within four weeks of enrollment severe elevated serum calcium heart failure receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment known allergies to agents used in bortezomib (e.g., boron or mannitol) poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scios, Inc. Clinical Trial
    Organizational Affiliation
    Scios, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

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