Long-Term Follow Up Study for AMD3100 Patients

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00476294

Collaborator

AnorMED (Industry)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloma	Other: Telephone Questionnaire

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.

Study Design

Study Type:

Observational

Actual Enrollment :

7 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Group 1: G + Placebo G-CSF plus Placebo Arm (G + Placebo)	Other: Telephone Questionnaire Follow-Up Telephone Calls Every 6 Months for 5 Years. Other Names: Survey
Group 2: G + AMD3100 G-CSF plus AMD3100 Arm (G + AMD3100)	Other: Telephone Questionnaire Follow-Up Telephone Calls Every 6 Months for 5 Years. Other Names: Survey

Arm

Intervention/Treatment

Group 1: G + Placebo

G-CSF plus Placebo Arm (G + Placebo)

Other: Telephone Questionnaire

Follow-Up Telephone Calls Every 6 Months for 5 Years.

Other Names:

Survey

Group 2: G + AMD3100

G-CSF plus AMD3100 Arm (G + AMD3100)

Other: Telephone Questionnaire

Follow-Up Telephone Calls Every 6 Months for 5 Years.

Other Names:

Survey

Outcome Measures

Primary Outcome Measures

Progression-free Survival at 5 Years [5 Years]
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]).
Overall survival at 5 Years [5 years]
Overall survival defined as number of participants alive after a period of five years following the first dose of study treatment (placebo or plerixafor [AMD3100]).