Autologous TransplantationPhase 2NCT01149863
Alteration in Timing of Plerixafor Administration
A Phase 2 study testing Plerixafor in people with Autologous Transplantation, run by Emory University at 1 site in United States.
Trial summary
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Transplantation
- What is being tested?
- Plerixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- MM patients in first or second complete or partial remission
- ECOG performance status of 0 or 1
- Up to 3 prior treatment regimens
- Meet all eligibility requirements for autologous transplant
- Adequate marrow function defined as WBC >3,000; ANC >1,500/mm3 ; Platelets >75,000/mm3
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- Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
- Adequate liver function defined as AST/ALT/Bilirubin < 2 times upper limit of normal
- Able to provide informed consent
- Women not pregnant and agree to use contraception
Who cannot join
- High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
- Brain metastases or carcinomatous meningitis
- Previous treatment with high dose chemotherapy and autologous transplant.
- Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors.
- Acute infection or unexplained fever >38°C
- Weight > 175% of ideal body weight as defined by the Devine equation.
- Experimental therapy within 4 weeks
- Cytokine administration in the previous 14 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: WCI1680-09: Evaluation of Alterations in Time of Administration of Plerixafor (Mozobil ®, AMD3100) in Combination With G-CSF on Safety and CD34+ Cell Mobilization
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.
The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.
We will also assess the safety of giving plerixafor 17 hours before apheresis.
- Conditions
- Autologous Transplantation
- Being tested
- Plerixafor
- Keywords
- Autologous Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called AMD3100, Mozobil
Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor 17 hours prior to apheresis | Experimental | Dosing of plerixafor will occur at 3PM (1500 hours). Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.
Measured: Within the first 5 days following plerixafor initiation
Secondary outcomes (1)
Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs
Measured: Within the first 5 days following plerixafor initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autologous TransplantationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, R. Donald Harvey, PharmD, Emory University
- Investigators
- R. Donald Harvey, PharmD, FCCP, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149863
- Sponsor's protocol ID
- IRB00034057
- Other IDs
- WCI1680-09
- Status last verified
- May 2013
- First submitted
- 22 Jun 2010
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WCI1680-09: Evaluation of Alterations in Time of Administration of Plerixafor (Mozobil ®, AMD3100) in Combination With G-CSF on Safety and CD34+ Cell Mobilization
- ClinicalTrials.gov ID
- NCT01149863
- Acronym / sponsor ID
- IRB00034057
- Conditions
- Autologous Transplantation
- Keywords
- Autologous Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Posted 8 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.
The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.
We will also assess the safety of giving plerixafor 17 hours before apheresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plerixafor 17 hours prior to apheresis | Experimental | Drug: PlerixaforDosing of plerixafor will occur at 3PM (1500 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years
- MM patients in first or second complete or partial remission
- ECOG performance status of 0 or 1
- Up to 3 prior treatment regimens
- Meet all eligibility requirements for autologous transplant
Key exclusion criteria (8 listed)
- High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
- Brain metastases or carcinomatous meningitis
- Previous treatment with high dose chemotherapy and autologous transplant.
- Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors.
- Acute infection or unexplained fever >38°C
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 |
|---|---|---|
| PlerixaforAlso: AMD3100, MozobilPlerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. | Drug | Plerixafor 17 hours prior to apheresis |
Primary outcome
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.
Time frame: Within the first 5 days following plerixafor initiation
1 secondary outcome
Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs
Time frame: Within the first 5 days following plerixafor initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
R. Donald Harvey, PharmD, FCCP principal investigator
Emory University Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plerixafor in people with Autologous Transplantation, run by Emory University 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 10 inclusion and 8 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 13 Dec 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. (time frame: Within the first 5 days following plerixafor initiation). 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 13 Dec 2013.