|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
M.D. Anderson Cancer Center AnorMED |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00476294 |
Purpose
Primary Objective:
1. To assess disease-free survival and overall survival in transplanted MM patients for a period of three years following the initial 12-month post-transplantation follow-up of the investigational study (protocol AMD3100-3102).
| Condition | Intervention |
|---|---|
|
Myeloma |
Other: Telephone Call |
| Study Type: | Observational |
| Study Design: | Case Control, 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 |
| Estimated Enrollment: | 330 |
| Study Start Date: | October 2006 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients who received a stem cell transplant after treatment with AMD3100 and G-CSF.
|
Other: Telephone Call
Follow-Up Telephone Calls Every 6 Months X 4 Years.
|
|
2
Patients who received a stem cell transplant after treatment with Placebo and G-CSF.
|
Other: Telephone Call
Follow-Up Telephone Calls Every 6 Months X 4 Years.
|
If you choose to take part in this study, you or your immediate family will be contacted by telephone, or will be spoken to during a routine or already scheduled clinic visit, at 1½ years, 2 years, 2½ years, 3 years, 3½ years, and 4 years after your stem cell transplant. You or your family member will be asked questions about how you are doing, any side effects you may be experiencing, and your blood counts (if known). This questionnaire will take about 10 minutes each time.
If you are not available to take one or more of the phone calls, you may choose to allow the required information to be released by a family member, your doctor, or both.
After the phone call at 4 years after your stem cell transplant, your participation in this study will be over. At that time, phone calls to your family member and/or doctor would stop as well.
This is an investigational study. Up to 330 patients will participate in this multicenter study. Up to 12 will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
1) All patients who received a stem cell transplant in protocol AMD3100-3102 (2004-0982)
Exclusion Criteria: None
Contacts and Locations| Contact: Chitra M. Hosing, MD | 713-792-8750 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Chitra M. Hosing, MD | |
| Principal Investigator: | Chitra M. Hosing, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Chitra M. Hosing, MD/Assoc. Professor ) |
| Study ID Numbers: | 2006-0665 |
| Study First Received: | May 17, 2007 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00476294 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Disease-Free Survival AMD3100 G-CSF Autologous Transplantation |
|
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases JM 3100 Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
|
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Anti-Retroviral Agents |
Immune System Diseases Therapeutic Uses Cardiovascular Diseases Antiviral Agents Pharmacologic Actions |
