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Status:

TERMINATED

S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Lead Sponsor:

SWOG Cancer Research Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in differen...

Detailed Description

OBJECTIVES: * Determine the confirmed overall response rate (complete remission, remission, and partial remission) in patients with relapsed or refractory multiple myeloma treated with bortezomib, th...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of multiple myeloma (MM)
  • Active disease
  • Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation
  • Relapse is defined as the occurrence of any of the following during or after prior treatment:
  • Myeloma protein level increase by \> 100% from the lowest previously recorded level
  • Myeloma protein level increase above the defined response criteria for partial remission
  • Reappearance of any myeloma peak that had disappeared during the prior treatment
  • Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan
  • Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy
  • Measurable disease
  • No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome
  • Must be registered on protocol SWOG-S0334
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-2 (unless due to bone pain)
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 50,000/mm\^3
  • Hepatic
  • AST or ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 3 times ULN
  • Renal
  • Creatinine clearance \> 30 mL/min
  • Cardiovascular
  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past 6 months
  • No poorly controlled hypertension
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients)
  • No blood, ova, or sperm donation during study treatment
  • No active infection requiring antibiotics
  • No neurotoxicity ≥ grade 2
  • No diabetes mellitus
  • No other serious medical or psychiatric illness that would preclude study treatment
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • Chemotherapy
  • At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • At least 14 days since prior radiotherapy and recovered
  • Surgery
  • Not specified
  • Other
  • No prior bortezomib alone or combined with thalidomide
  • Concurrent participation on protocol SWOG-S0309 allowed

Exclusion

    Key Trial Info

    Start Date :

    August 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2010

    Estimated Enrollment :

    7 Patients enrolled

    Trial Details

    Trial ID

    NCT00124579

    Start Date

    August 1 2005

    End Date

    June 1 2010

    Last Update

    August 9 2018

    Active Locations (127)

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    Page 1 of 32 (127 locations)

    1

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    2

    Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, United States, 62002

    3

    Good Samaritan Regional Health Center

    Mount Vernon, Illinois, United States, 62864

    4

    Hematology Oncology Consultants - Naperville

    Naperville, Illinois, United States, 60540