Multiple MyelomaPhase 2NCT01037517
Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
A Phase 2 study testing Plerixafor and Observation: Nonintervention in people with Multiple Myeloma and Lymphoma, run by CancerCare Manitoba at 1 site in Canada.
Trial summary
Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Lymphoma
- What is being tested?
- Plerixafor and Observation: Nonintervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Aug 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18 years of age or older
- Patients must be able to provide written consent
- Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
- Females of child bearing age will be asked to use an approved form of contraception
Who cannot join
- Patients who are pregnant or breastfeeding
- Patients whose creatinine ≥ 250 μM
- Serum AST, ALT or total bilirubin >5X upper limit of normal
- Acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.
OBJECTIVES
To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:
- increase the number of patients successfully collected in one day
- increase the number of patients successfully mobilized on first collection attempt
- is cost neutral within a Canadian setting
- Conditions
- Multiple Myeloma, Lymphoma
- Being tested
- Plerixafor, Observation: Nonintervention
- Keywords
- Myeloma, Multiple Myeloma or Lymphoma Patients undergoing, mobilization for the purpose of autologous stem cell collection
- Medical subject headings
- Multiple Myeloma, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called Mozobil®
Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day
Observation: NoninterventionOther
Nonintervention group, no drug will be given, observation only
| Study group | Role | What they receive |
|---|---|---|
| Successful Mobilizers | Active comparator | Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L. Receives: Other: Observation: Nonintervention |
| Poor Mobilizers | Experimental | Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.
Measured: within 1-2 days after commencing therapy
Secondary outcomes (4)
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.
Measured: After therapy
To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor
Measured: After therapy
To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor
Measured: After therapy
To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization
Measured: After therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Szwajcer, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037517
- Sponsor's protocol ID
- CCM-002
- Status last verified
- Oct 2013
- First submitted
- 18 Dec 2009
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
- ClinicalTrials.gov ID
- NCT01037517
- Acronym / sponsor ID
- CCM-002
- Conditions
- Multiple Myeloma, Lymphoma
- Keywords
- Myeloma, Multiple Myeloma or Lymphoma Patients undergoing, mobilization for the purpose of autologous stem cell collection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Dec 2009 (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.
Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.
OBJECTIVES
To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:
- increase the number of patients successfully collected in one day
- increase the number of patients successfully mobilized on first collection attempt
- is cost neutral within a Canadian setting
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful Mobilizers | Active comparator | Other: Observation: NoninterventionSuccessful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L. |
| Poor Mobilizers | Experimental | Drug: PlerixaforPoor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be 18 years of age or older
- Patients must be able to provide written consent
- Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
- Females of child bearing age will be asked to use an approved form of contraception
Key exclusion criteria (4 listed)
- Patients who are pregnant or breastfeeding
- Patients whose creatinine ≥ 250 μM
- Serum AST, ALT or total bilirubin >5X upper limit of normal
- Acute infection
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: Mozobil®Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day | Drug | Poor Mobilizers |
| Observation: NoninterventionNonintervention group, no drug will be given, observation only | Other | Successful Mobilizers |
Primary outcome
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.
Time frame: within 1-2 days after commencing therapy
4 secondary outcomes
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.
Time frame: After therapy
To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor
Time frame: After therapy
To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor
Time frame: After therapy
To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization
Time frame: After therapy
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 31 Oct 2013.
- Official CancerCare Manitoba WebsiteLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Observation: Nonintervention in people with Multiple Myeloma and Lymphoma, run by CancerCare Manitoba at 1 site in Canada.
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 4 inclusion and 4 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 31 Oct 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 Canada. 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?
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?
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%. (time frame: within 1-2 days after commencing therapy). 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 31 Oct 2013.