Multiple MyelomaPhase 2NCT00395967
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
A Phase 2 study testing G-CSF plus plerixafor in people with Multiple Myeloma and Lymphoma, Non-Hodgkin's, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial summary
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Lymphoma, Non-Hodgkin's
- What is being tested?
- G-CSF plus plerixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Aug 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)
- Eligible for autologous transplantation
- <=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- >4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- Total dose of melphalan ≦200 mg
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
Show all 13Show fewer
- White blood cell (WBC) count >3.0*10^9/L prior to first dose of G-CSF
- Absolute polymorphonuclear leukocyte (PMN) count >1.5*10^9/L prior to first dose of G-CSF
- Platelet (PLT) count >100*10^9/L prior to first dose of granulocyte colony-stimulating factor (G-CSF)
- Serum creatinine ≥2.2 mg/dL
- SGOT, SGPT and total bilirubin <2 times upper limit of normal (ULN)
- Negative for HIV
- CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G-CSF alone
Who cannot join
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
- Failed previous stem cell collection or collection attempts
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or carcinomatous meningitis
- Active infection requiring antibiotic treatment
- Received prior radio-immunotherapy with Zevalin or Bexxar
Show all 11Show fewer
- Received bone-seeking radionuclides (e.g., holmium)
- Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
- History of ventricular arrhythmias, including electrocardiogram (ECG)-documented premature ventricular contractions (PVCs), during the last 3 years
- Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
- Had an apheresis yield >1.3*10^6 CD34+ cells/kg on Day 5 (Applicable only to patients who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of 8-19 cells/µl inclusive).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center - Adult BMT Program
Durham, North Carolina, 27705
About this study
Official title: Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria.
The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Read the detailed description
A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis.
Following screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the fifth day.
On Day 5, if the patient's peripheral CD34+ cell count was <5 cells/µl or ≥20 cells/µl, the patient did not enter this study and was treated as per the policy of the study site.
On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg are collected.
On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive), then he/she underwent apheresis that day. If this apheresis yield was <1.3*10^6 CD34+ cells/kg, then the patient was predicted to be unlikely to collect ≥2*10^6 CD34+ cells/kg in ≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the apheresis yield on Day 5 was ≥1.3*10^6 CD34+ cells/kg, then the patient did not enter the study.
The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis yield was at least double the apheresis yield on Day 5, then the patient received another 10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg were collected.
All patients, after the completion of apheresis procedures (or after ≥5*10^6 cells/kg were collected), received high-dose chemotherapy in preparation for transplantation. Patients were transplanted with cells collected after receiving plerixafor with G-CSF. However, if there were insufficient cells, cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone.
Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells harvested during apheresis.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
- Conditions
- Multiple Myeloma, Lymphoma, Non-Hodgkin's
- Being tested
- G-CSF plus plerixafor
- Keywords
- Non-Hodgkin's Lymphoma, Multiple Myeloma, stem cell mobilization, autologous transplantation, AMD3100
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF plus plerixaforDrug
Also called Mozobil, AMD3100
Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | Patients who were predicted to be unable to mobilize a minimum number of cells (≥2*10^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation. Receives: Drug: G-CSF plus plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days
The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.
Measured: approximately days 6-9
Secondary outcomes (5)
Overall Participants Counts of Adverse Events
Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
Measured: up to 13 months
The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
This study was terminated early and analysis was not done.
Measured: Days 5-6
Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.
This study was terminated early and analysis was not done.
Measured: 2 months
Number of Days to Platelet (PLT) Engraftment
The median number of days to platelet (PLT) engraftment criteria was ≥ 20*10^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.
This study was terminated early and analysis was not done.
Measured: 2 months
Graft Durability at 12 Months After Transplantation
Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.
This study was terminated early and analysis was not done.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startApr 2005
- Primary completionJul 2005
- Study completionAug 2006
Why it stopped: Enrollment terminated in 2005 to focus on Phase 3 study enrollment.
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 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395967
- Sponsor's protocol ID
- AMD3100-2109
- Status last verified
- Apr 2015
- First submitted
- 2 Nov 2006
- Last updated
- 1 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone
- ClinicalTrials.gov ID
- NCT00395967
- Acronym / sponsor ID
- AMD3100-2109
- Conditions
- Multiple Myeloma, Lymphoma, Non-Hodgkin's
- Keywords
- Non-Hodgkin's Lymphoma, Multiple Myeloma, stem cell mobilization, autologous transplantation, AMD3100
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment terminated in 2005 to focus on Phase 3 study enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Posted 13 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria.
The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Detailed description
A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis.
Following screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the fifth day.
On Day 5, if the patient's peripheral CD34+ cell count was <5 cells/µl or ≥20 cells/µl, the patient did not enter this study and was treated as per the policy of the study site.
On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg are collected.
On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive), then he/she underwent apheresis that day. If this apheresis yield was <1.3*10^6 CD34+ cells/kg, then the patient was predicted to be unlikely to collect ≥2*10^6 CD34+ cells/kg in ≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the apheresis yield on Day 5 was ≥1.3*10^6 CD34+ cells/kg, then the patient did not enter the study.
The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis yield was at least double the apheresis yield on Day 5, then the patient received another 10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg were collected.
All patients, after the completion of apheresis procedures (or after ≥5*10^6 cells/kg were collected), received high-dose chemotherapy in preparation for transplantation. Patients were transplanted with cells collected after receiving plerixafor with G-CSF. However, if there were insufficient cells, cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone.
Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells harvested during apheresis.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: G-CSF plus plerixaforPatients who were predicted to be unable to mobilize a minimum number of cells (≥2*10^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)
- Eligible for autologous transplantation
- <=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- >4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
- Total dose of melphalan ≦200 mg
Key exclusion criteria (11 listed)
- A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
- Failed previous stem cell collection or collection attempts
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or carcinomatous meningitis
- Active infection requiring antibiotic treatment
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 |
|---|---|---|
| G-CSF plus plerixaforAlso: Mozobil, AMD3100Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis. | Drug | All Patients |
Primary outcome
Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days
Time frame: approximately days 6-9
The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.
5 secondary outcomes
Overall Participants Counts of Adverse Events
Time frame: up to 13 months
The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor
Time frame: Days 5-6
Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Time frame: 2 months
Number of Days to Platelet (PLT) Engraftment
Time frame: 2 months
Graft Durability at 12 Months After Transplantation
Time frame: 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- 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.
Medical Monitor study director
Genzyme, a Sanofi Company
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 G-CSF plus plerixafor in people with Multiple Myeloma and Lymphoma, Non-Hodgkin's, run by Genzyme, a Sanofi Company 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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 1 May 2015. 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 13 Aug 2010). 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 Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days (time frame: approximately days 6-9). 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 1 May 2015.