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A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria: Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG) Adequate bone marrow reserve Adequate hepatic and renal function Ability to swallow capsules 3 weeks or more from prior chemotherapy and have recovered from prior toxicities Exclusion Criteria: Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism Patients with other active/uncontrolled clinically significant illnesses Pregnant or nursing female patients

Sites / Locations

    Outcomes

    Primary Outcome Measures

    PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
    PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.

    Secondary Outcome Measures

    1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.

    Full Information

    First Posted
    April 22, 2005
    Last Updated
    November 13, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00109109
    Brief Title
    A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
    Official Title
    Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 1, 2003 (Actual)
    Primary Completion Date
    February 14, 2006 (Actual)
    Study Completion Date
    February 14, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purposes of this study are: To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma; To assess the safety and overall response rate to SAHA in patients with advanced 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 1
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
    Primary Outcome Measure Information:
    Title
    PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
    Title
    PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
    Secondary Outcome Measure Information:
    Title
    1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG) Adequate bone marrow reserve Adequate hepatic and renal function Ability to swallow capsules 3 weeks or more from prior chemotherapy and have recovered from prior toxicities Exclusion Criteria: Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism Patients with other active/uncontrolled clinically significant illnesses Pregnant or nursing female patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18297527
    Citation
    Richardson P, Mitsiades C, Colson K, Reilly E, McBride L, Chiao J, Sun L, Ricker J, Rizvi S, Oerth C, Atkins B, Fearen I, Anderson K, Siegel D. Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma. Leuk Lymphoma. 2008 Mar;49(3):502-7. doi: 10.1080/10428190701817258.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis Link
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

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