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Status:

TERMINATED

Vorinostat, Bortezomib, and Doxorubicin Hydrochloride Liposome in Treating Patients With Relapsed or Refractory Multiple Myeloma

Lead Sponsor:

UNC Lineberger Comprehensive Cancer Center

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Millennium Pharmaceuticals, Inc.

Conditions:

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma by blocking blo...

Detailed Description

OBJECTIVES: Primary * To determine the maximum tolerated dose of vorinostat when added to the standard regimen of bortezomib and pegylated liposomal doxorubicin hydrochloride in patients with relaps...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of multiple myeloma
  • Relapsed or refractory disease
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 1.0 x 10\^9/L (no granulocyte growth factor support, e.g., G-CSF or GM-CSF allowed)
  • Platelet count ≥ 100 x 10\^9/L (erythropoietin allowed, no platelet or RBC transfusion within the past 2 weeks)
  • Hemoglobin ≥ 8 g/dL (erythropoietin allowed, no platelet or RBC transfusion within the past 2 weeks)
  • Creatinine clearance ≥ 30 mL/min
  • AST or ALT ≤ 2.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • LVEF ≥ 45% by MUGA or ECHO
  • Symptomatic neuropathy \< grade 2
  • No known history of HIV
  • No active or serious infection, medical or psychiatric illness that would preclude study participation
  • No active hepatitis B or C infection
  • No other prior or concurrent malignancy except for adequately treated basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate cancer after curative therapy, or other cancer for which the patient has been disease-free for ≥ 3 years
  • No history of hypersensitivity reaction to bortezomib or any of its components (boron, mannitol), vorinostat, doxorubicin hydrochloride, or any of the components of PLD
  • No serum potassium ≤ 3.0 or serum magnesium ≤ 1.6 that cannot be corrected with supplementation are excluded
  • Patients must have adequate cardiovascular function, defined by all of the following:
  • No EKG evidence of active, clinically significant conduction system abnormalities
  • No EKG evidence of QTc prolongation \> grade 2
  • NOTE: Any EKG abnormality at screening has to be documented by the investigator as not medically significant.
  • PRIOR CONCURRENT THERAPY:
  • No limit to number of prior treatment regimens
  • At least 30 days since prior therapy and recovered
  • At least 3 months since prior autologous stem cell transplantation and recovered
  • Prior allogeneic stem cell or bone marrow transplantation allowed provided the following criteria are met:
  • More than 1 year since transplantation
  • No longer receiving immunosuppressive therapy or treatment for graft-versus-host disease (GVHD) prophylaxis
  • No active GVHD
  • No active, uncontrolled infections
  • No major surgery within the past 3 weeks
  • No prior anthracycline dose \> 360 mg/m\^2 for doxorubicin hydrochloride (including pegylated liposomal doxorubicin hydrochloride \[PLD\]) or 720 mg/m\^2 for epirubicin hydrochloride
  • No prior or concurrent histone deacetylase inhibitor (e.g., valproic acid)
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) during course 1
  • No other concurrent investigational or anticancer agent

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2015

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT00744354

    Start Date

    October 1 2008

    End Date

    April 1 2015

    Last Update

    January 18 2018

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Mount Sinai Medical Center

    New York, New York, United States, 10029

    2

    Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States, 27599-7295

    3

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710

    4

    Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, United States, 27157-1096