Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476294
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2007-05-17
Brief Title:
Long-Term Follow Up Study for AMD3100 Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Long-Term Observational Follow-Up Study of a Multicenter Randomized Double-Blind Placebo-Controlled Comparative Trial of AMD3100 240 MCGKG Plus G-CSF 10 MCGKG Versus G-CSF 10 MCGKG Plus Placebo to Mobilize and Collect 6 x 106 CD34 CellsKG in Multiple Myeloma Patients for Autologous Transplantation
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 drugplacebo 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 drugplacebo 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
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 drugplacebo 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 drugplacebo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None