MyelomaNCT00476294
Long-Term Follow Up Study for AMD3100 Patients
An observational study of Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Myeloma
- What is being tested?
- Telephone Questionnaire
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Myeloma
- Being tested
- Telephone Questionnaire
- Keywords
- Multiple Myeloma, Disease-Free Survival, AMD3100, G-CSF, Autologous Transplantation
- Medical subject headings
- Neoplasms, Plasma Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone QuestionnaireOther
Also called Survey
Follow-Up Telephone Calls Every 6 Months for 5 Years.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: G + Placebo | G-CSF plus Placebo Arm (G + Placebo) Receives: Other: Telephone Questionnaire | |
| Group 2: G + AMD3100 | G-CSF plus AMD3100 Arm (G + AMD3100) Receives: Other: Telephone Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival at 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]).
Measured: 5 Years
Overall survival at 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]).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startOct 2006
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AnorMED
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476294
- Sponsor's protocol ID
- 2006-0665
- Status last verified
- Jul 2012
- First submitted
- 17 May 2007
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00476294
- Acronym / sponsor ID
- 2006-0665
- Conditions
- Myeloma
- Keywords
- Multiple Myeloma, Disease-Free Survival, AMD3100, G-CSF, Autologous Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- AnorMED
- Study start
- Oct 2006
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: G + Placebo | – | Other: Telephone QuestionnaireG-CSF plus Placebo Arm (G + Placebo) |
| Group 2: G + AMD3100 | – | Other: Telephone QuestionnaireG-CSF plus AMD3100 Arm (G + AMD3100) |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone QuestionnaireAlso: SurveyFollow-Up Telephone Calls Every 6 Months for 5 Years. | Other | Group 1: G + Placebo, Group 2: G + AMD3100 |
Primary outcome
Progression-free Survival at 5 Years
Time frame: 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
Time frame: 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]).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chitra M. Hosing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival at 5 Years (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.