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Status:

COMPLETED

Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

Lead Sponsor:

Valerio Therapeutics

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. ...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Signed informed consent
  • A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.
  • Diagnostic criteria for multiple myeloma:
  • A Monoclonal immunoglobulin (M-component) in serum of IgG-type \> 30 g/l, of IgA type \> 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type \> 1 g/24 hours.
  • B M-component in serum and/or urine in lower concentration than indicated above in 'A'.
  • C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor D Osteolytical bone lesions.
  • The diagnosis of multiple myeloma demands one of the following combinations: A+C, A+D, or B+C+D.
  • Evaluable disease (as defined above)
  • Adequate bone marrow and hepatic functions including the following:
  • WBC \> 2.5 x 109/l, absolute neutrophil count ≥ 1.5 x 109/l, platelets ≥ 50x109/l
  • Total bilirubin ≤1.5 x upper normal limit.
  • AST (SGOT), ALT (SGPT) ≤2.5 x upper normal limit
  • Serum potassium within normal range.
  • Age ≥18 years
  • Performance status (PS) ≤2 (ECOG scale)
  • Estimated life expectancy greater than 3 months
  • Female patients with reproductive potential with a negative serum pregnancy test within the last 7 days before trial enrollment and use a safe contraceptive during and in a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive.
  • Exclusion criteria
  • Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
  • Active infection or any medical condition likely to interfere with trial procedures.
  • Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
  • A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval \>500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
  • Patients with renal insufficiency defined as a calculated creatinine clearance of \< 45 ml/min.
  • Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication.
  • Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
  • Other malignant diseases requiring treatment
  • Non-secretory multiple myeloma or symptomatic amyloidosis
  • Pregnant or breast-feeding women
  • Women of childbearing age and potential, who do not use effective contraception
  • Known HIV positivity

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2007

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00131261

    Start Date

    January 1 2005

    End Date

    June 1 2007

    Last Update

    July 8 2015

    Active Locations (10)

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    Page 1 of 3 (10 locations)

    1

    James Berenson, MD, Inc

    West Hollywood, California, United States, 90069

    2

    H. Lee Moffitt Cancer Center

    Tampa, Florida, United States, 33612

    3

    Northwestern University

    Chicago, Illinois, United States, 60611

    4

    Research Facility

    New York, New York, United States, 10021