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Long-Term Observational Follow-Up Study of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 MCG/KG) Plus G-CSF (10 MCG/KG) Versus G-CSF (10 MCG/KG) Plus Placebo to Mobilize and Collect >/= 6 x 10^6 CD34+ Cells/KG in Multiple Myeloma Patients for Autologous Transplantation


N/A
18 Years
78 Years
Not Enrolling
Both
Myeloma

Thank you

Trial Information

Long-Term Observational Follow-Up Study of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240 MCG/KG) Plus G-CSF (10 MCG/KG) Versus G-CSF (10 MCG/KG) Plus Placebo to Mobilize and Collect >/= 6 x 10^6 CD34+ Cells/KG in Multiple Myeloma Patients for Autologous Transplantation


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.


Inclusion Criteria:



- 1) All patients who received the study drug (placebo or plerixafor) on protocol
AMD3100-3102 (2004-0982)

Exclusion Criteria: None

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Progression-free Survival at 5 Years

Outcome Description:

Progression-free survival defined as number of participants without disease progression at five years following the first dose of study treatment (placebo or plerixafor [AMD3100]).

Outcome Time Frame:

5 Years

Safety Issue:

No

Principal Investigator

Chitra M. Hosing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0665

NCT ID:

NCT00476294

Start Date:

October 2006

Completion Date:

July 2012

Related Keywords:

  • Myeloma
  • Multiple Myeloma
  • Disease-Free Survival
  • AMD3100
  • G-CSF
  • Autologous Transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030