Last updated on August 2013

High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Newly Diagnosed Stage I Stage II or Stage III Multiple Myeloma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma and Plasma Cell Neoplasm
  • Age: Between 18 - 70 Years
  • Gender: Male or Female
  • Other:
    Diagnosis of symptomatic stage I or stage II-III multiple myeloma
    Newly diagnosed disease
    No amyloidosis
    ECOG performance status 0-2
    ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors)
    Platelet count ≥ 50 x 10^9/L (without transfusion support within the past 7 days)
    Serum calcium < 14 mg/dL
    AST and ALT ≤ 2.5 times upper limit of normal (ULN)
    Total bilirubin ≤ 1.5 times ULN
    Creatinine clearance ≥ 50 mL/min
    Fertile patients must use effective contraception
    Negative pregnancy test
    Willing and able to comply with protocol requirements

You may not be eligible for this study if the following are true:

  • Myocardial infarction within the past 6 months
    New York Heart Association class III or IV heart failure
    Uncontrolled angina
    Severe uncontrolled ventricular arrhythmia
    Acute ischemia or active conduction system abnormalities as evidenced by ECG
    Serious medical condition that could prolong hematological recovery or preclude
    completion of or tolerance to protocol therapy
    Seropositive for HIV antibody
    Known hepatitis B surface antigen positivity OR active hepatitis C infection
    Active systemic infection requiring treatment
    Pregnant or nursing
    Poor psychiatric condition
    No plasmapheresis within the past 4 weeks
    No major surgery within the past 4 weeks
    No anticancer therapy within the past 5 years, except treatment for basal cell
    carcinoma of the skin or carcinoma in situ of the uterine cervix
    No other concurrent G-CSF growth factors
    No concurrent enrollment in another investigational clinical trial
    No concurrent investigational agent that would contraindicate the use of
    pegfilgrastim as either a mobilization agent or a hematological recovery agent

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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