Long-Term Follow Up Study for AMD3100 Patients
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

Summary: 
      Objectives:

      The objective of this long-term observational study is to assess progression-free survival
      and overall survival for a period of five years following the first dose of study treatment
      (placebo or plerixafor [AMD3100]) in protocol AMD3100-3102. Patients that received at least 1
      dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind,
      placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus
      granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize
      hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are
      eligible.
    

Detailed description: 
      Informed Consent Process:

      Your study doctor or staff will either meet with you in person or contact you by phone to
      review the study information. You will be given a copy of this consent form to review and ask
      questions.

      If you agree to take part in this study, you should sign this consent form on the date that
      you agree to be in the study. If you agree to take part during a phone call with a member of
      the study team, you should sign and date the form right away, on the date of the phone call,
      and mail the form to the study doctor or staff. Please keep a copy for your own reference.

      5-Year Follow-Up: You will be contacted by phone or in person at a visit, every 6 months for
      5 years from the time of your first study drug/placebo dose in the 2004-0982 study. A placebo
      is a substance that looks like the study drug but has no active ingredients.

      If you received a transplant in the 2004-0982 study, your first contact in this study will
      either be about 18 months from the time you began the 2004-0982 study, or at the time you
      sign this consent form.

      If you did not receive a transplant, your first contact in this study will be at the time you
      sign this consent form.

      At your first visit or call, you will be asked about the status of the disease, any changes
      in the multiple myeloma that may have occurred since the 2004-0982 study, and any additional
      treatments you may have received during that time.

      At every visit or call after that, you will be asked about the status of the multiple
      myeloma, any changes in the disease, and any treatments you have received since the last
      visit or call. These questionnaires will take about 10 minutes each time.

      Your doctor or the study staff also may contact your local doctor in order to collect
      information from your medical records or for information about your medical history and
      disease status.

      Length of Study Participation:

      You will be off study after your last study phone call or visit (about 5 years after your
      first study drug/placebo dose in the 2004-0982 study).

      This is an investigational study. Up to 300 patients will participate in this multi-center
      study. Up to 12 will be enrolled at MD Anderson.
    

Intervention name(s): Telephone Questionnaire
Intervention type(s): Other
Intervention description(s): Follow-Up Telephone Calls Every 6 Months for 5 Years.
Other intervention name(s): Survey
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who were randomized in a double-blind study and received a stem cell transplant
        after treatment with AMD3100 and G-CSF OR treatment with Placebo and G-CSF.
      
Keywords: Multiple Myeloma; Disease-Free Survival; AMD3100; G-CSF; Autologous Transplantation