LymphomaPhase 2NCT00665314
Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).
A Phase 2 study testing Plerixafor (AMD3100) and Can be any registered nonpegylated form of G-CSF in people with Lymphoma and Non Hodgkin's Lymphoma, run by Genzyme, a Sanofi Company at 5 sites in Germany.
Trial summary
Some patients with multiple myeloma or lymphoma will need treatment with high dose chemotherapy to treat their condition. This potent treatment will kill many of the blood-forming cells in the bone marrow. The patient will therefore need these blood-forming cells replaced after the chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Lymphoma, Non Hodgkin's Lymphoma, Hodgkin's Disease
- What is being tested?
- Plerixafor (AMD3100) and Can be any registered nonpegylated form of G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesGermany
- Study dates
- Nov 2007to Jun 2009
- 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 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible to undergo autologous transplantation.
- Diagnosis of NHL, HD or MM [patients with plasma cell leukemia or other leukemias including chronic lymphocytic leukemia (CLL), are excluded].
- In the last collection attempt prior to entry into this trial, the patient has failed to collect 0.8x10^6 cells/kg in at least 2 apheresis sessions or 2x10^6 cells/kg in 4 apheresis sessions using a mobilization regimen of chemotherapy, with or without G-CSF.
- A minimum of a 7 day interval between last collection attempt and randomization.
- Cardiac, pulmonary and renal function deemed clinically adequate to be able to undergo mobilization and transplant.
- Performance status, Eastern Cooperative Oncology Group (ECOG) of 0 or 1
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- ≥ 21 days between the last cycle of chemotherapy and randomization (thalidomide, dexamethasone, and other corticosteroids, Rituxan® and Velcade® are not considered prior chemotherapy for the purpose of this study).
- The patient has recovered from all acute toxic effects of prior chemotherapy.
- WBC ≥ 2.5x10^9/l.
- Absolute neutrophil count ≥ 1.5x10^9/l.
- Platelet count ≥ 75x10^9/l.
- Adequate renal function as demonstrated by serum creatine ≤ or equal to 2.2 mg/dl or creatinine clearance (24 hr urine collection)≥ 60 ml/min
- Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT) and total bilirubin ≤ 2.5 x upper limit of normal (ULN).
- Signed informed consent.
- All patients must agree to use a highly effective method of contraception (including both female patients of child-bearing potential and male patients with child-bearing potential partners). Effective birth control includes: a) birth control pills, depo-progesterone, or an IUD PLUS one barrier method, or b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using hormonal contraceptive method, information about any interaction of MAD3100 with hormonal contraceptives is not known.
Who cannot join
- A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications.
- A residual acute medical condition resulting from prior chemotherapy.
- Received thalidomide, dexamethasone or corticosteroids, Rituxan® and Velcade® within 7 days prior to randomization.
- Brain metastases or carcinomatous meningitis.
- Active acute or chronic infection or anti-infective therapy within 1 week prior to randomization.
- Fever (temperature ≥ 38 degrees celsius).
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- Hypercalcemia (≥ 1mg/dl above the ULN).
- Known to be HIV-positive.
- Pregnant and nursing females.
- Patient unwilling to implement adequate birth control (including both female patients of child-bearing potential and male patients with child-bearing potential partners).
- Patients who previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the Mobilization phase.
- Patients who have failed previous collection attempt within 7 days or less from randomization.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Study site
Berlin
Study site
Cologne
Study site
Dresden
Study site
Nuremberg
Study site
Würzburg
About this study
Official title: A Multicenter, Randomized, Comparative, Patient-blinded Study to Evaluate the Safety and Efficacy of G-CSF Alone Versus AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Adult Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkins Disease (HD) or Multiple Myeloma (MM) Who Have Previously Failed Stem Cell Collections or Collection Attempts
Some patients with multiple myeloma or lymphoma will need treatment with high dose chemotherapy to treat their condition. This potent treatment will kill many of the blood-forming cells in the bone marrow. The patient will therefore need these blood-forming cells replaced after the chemotherapy treatment. This is done by collecting some of teh patients own blood-forming stem cells before chemotherapy, storing them and then infusing them into the patient after chemotherapy (in the same way as a blood transfusion is given). The stem cells will then make their way unto the bone marrow and re-populate it. Having stem cells collected and returned later is called an "Autologous Transplant".
In most patients these blood-forming stem cells (which normally live in the bone marrow) are "mobilized" into the blood stream where they are then collected by a process called apheresis (a bit like donating blood). This process of mobilization is not always successful. In this study patients who did not collect enough stem cells in a previous cell collection attempt to have an autologous stem cell transplant will participate. Patients will be mobilized with G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.
Read more
AMD3100 is a member of a new class of medications called "chemokine inhibitors". The drug triggers the movement of stem cells out of the bone marrow into the blood stream. In previous studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in combination, a greater number of stem cells were mobilized into the blood stream than by using g-CSF alone.
The purposes of this study are to measure how many stem cells can be collected, the number of days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study will also evaluate how well the cells grow when transplanted.
Read the detailed description
This is a multicenter, randomized, comparative, patient-blinded study. Patients with NHL, HD or MM who would benefit from an autologous stem cell transplant, who failed previous collections or collection attempts with a mobilization regimen of chemotherapy with or wihoutG-CSF, and who meet the inclusion/exclusion criteria are eligible to receive AMD3100(240µg/kg) or placebo (both given as an evening dose).
Patients will undergo mobilization with G-CSF (10µg/kg) for 4 consecutive days. On Day 4, AMD3100 (240µg/kg) or placebo will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on each day of apheresis. G-CSF will be administered in the morning and approximately 1 hour prior to apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses until a minimum of 2x10^6 CD34+ cells/kg or greater than or equal to 5x10^6 CD34+cells/kg are collected. More cells may be collected, if done within the 7 aphereses. Patients who are to receive a tandem transplant will undergo a minimum of 2 and maximum of 7 aphereses until a minimum of 4x10^6 CD34+ cells/kg are collected. Aphereses should be performed on consecutive days (including weekend days)
The patient will have a peripheral blood (PB) sample collected to measure the number of CD34+ cell in PB at baseline prior to administration of G-CSF, prior to each administration of AMD3100 or placebo and at the initiation of apheresis. In addition, a sample will be obtained from each apheresis product to measure the number of CD34+ cells collected in the apheresis product.
Patients who fail to collect greater than or equal to 0.8x10^6 CD34+ cells/kg in 7 aphereses will be offered a rescue arm giving AMD3100 plus G-CSF.
Patients will undergo their ablative chemotherapy before transplantation. Patients will then be transplanted. The success of the transplantation will be evaluated. Graft durability will be evaluated to 12 months post-transplant. In the event that a sufficient number of cells for transplantation are not obtained from the collections, cells may be retained, pooled, and transplanted at a later date at the Investigator's discretion.
- Conditions
- Lymphoma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Being tested
- Plerixafor (AMD3100), Can be any registered nonpegylated form of G-CSF
- Keywords
- Mobilisation stem cells, G-CSF Mobilisation Regimen, Lymphoma, Multiple Myeloma, Adult patients with lymphoma (Non Hodgkin's Lymphoma, Hodgkin's Disease) or Multiple Myeloma who previously failed Stem Cell Collections or Collection attempts.
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plerixafor (AMD3100)Drug
0.24mg/kg SC for 2 to 7 days.
Can be any registered nonpegylated form of G-CSFDrug
10mcg/kg SC for 4 days followed by an additional 2 to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| AMD3100 added to a G-CSF Mobilisation regimen | Experimental | AMD3100 added to a G-CSF Mobilisation regimen Receives: Drug: Plerixafor (AMD3100) |
| G-CSF plus placebo | Active comparator | G-CSF plus placebo Receives: Drug: Can be any registered nonpegylated form of G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if patients reach a target of ≥ 2x10^6 CD34+ cells/kg within 2 days of apheresis in Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) patients who are proven poor mobilizer.
Measured: after last apheresis
Secondary outcomes (8)
To examine and compare the safety of both mobilization regimens, G-CSF plus AMD3100(240µg/kg) and G-CSF plus placebo in NHL, MM and HD patients.
Measured: After each dose of AMD3100
To measure the daily and total number of CD34+ cells harvested during apheresis.
Measured: After each dose of AMD3100
To measure the number of days of apheresis needed to harvest ≥ 2x10^6 CD34+ cells/kg.
Measured: After each dose of AMD3100 transplantation and engraftment
To measure the number of days of apheresis needed to harvest ≥ 5x10^6 CD34+ cells/kg.
Measured: After each dose of AMD3100, transplantation and engraftment
To determine the times of platelet (PLT) and polymorphonuclear leukocyte (PMN) engraftment.
Measured: After each dose of AMD3100, transplantation and engraftment
To evaluate the durability of engraftment.
Measured: After each dose of AMD3100, transplantation and engraftment
To determine if patient reach the Optimum Target of 5x10^6 CD34+ cells/kg within 4 days of apheresis.
Measured: After each dose of AMD3100, transplantation and engraftment
To determine if NHL tumor cells are mobilized after either G-CSF mobilization of AMD3100 administration
Measured: After G-CSF mobilization period and after each dose of AMD3100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665314
- Sponsor's protocol ID
- AMD3100-EU23
- Other IDs
- EudraCT number: 2006-00424729
- Status last verified
- Feb 2014
- First submitted
- 21 Apr 2008
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Comparative, Patient-blinded Study to Evaluate the Safety and Efficacy of G-CSF Alone Versus AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Adult Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkins Disease (HD) or Multiple Myeloma (MM) Who Have Previously Failed Stem Cell Collections or Collection Attempts
- ClinicalTrials.gov ID
- NCT00665314
- Acronym / sponsor ID
- AMD3100-EU23
- Conditions
- Lymphoma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Keywords
- Mobilisation stem cells, G-CSF Mobilisation Regimen, Lymphoma, Multiple Myeloma, Adult patients with lymphoma (Non Hodgkin's Lymphoma, Hodgkin's Disease) or Multiple Myeloma who previously failed Stem Cell Collections or Collection attempts.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Apr 2008 (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.
Some patients with multiple myeloma or lymphoma will need treatment with high dose chemotherapy to treat their condition. This potent treatment will kill many of the blood-forming cells in the bone marrow. The patient will therefore need these blood-forming cells replaced after the chemotherapy treatment. This is done by collecting some of teh patients own blood-forming stem cells before chemotherapy, storing them and then infusing them into the patient after chemotherapy (in the same way as a blood transfusion is given). The stem cells will then make their way unto the bone marrow and re-populate it. Having stem cells collected and returned later is called an "Autologous Transplant".
In most patients these blood-forming stem cells (which normally live in the bone marrow) are "mobilized" into the blood stream where they are then collected by a process called apheresis (a bit like donating blood). This process of mobilization is not always successful. In this study patients who did not collect enough stem cells in a previous cell collection attempt to have an autologous stem cell transplant will participate. Patients will be mobilized with G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.
AMD3100 is a member of a new class of medications called "chemokine inhibitors". The drug triggers the movement of stem cells out of the bone marrow into the blood stream. In previous studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in combination, a greater number of stem cells were mobilized into the blood stream than by using g-CSF alone.
The purposes of this study are to measure how many stem cells can be collected, the number of days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study will also evaluate how well the cells grow when transplanted.
Detailed description
This is a multicenter, randomized, comparative, patient-blinded study. Patients with NHL, HD or MM who would benefit from an autologous stem cell transplant, who failed previous collections or collection attempts with a mobilization regimen of chemotherapy with or wihoutG-CSF, and who meet the inclusion/exclusion criteria are eligible to receive AMD3100(240µg/kg) or placebo (both given as an evening dose).
Patients will undergo mobilization with G-CSF (10µg/kg) for 4 consecutive days. On Day 4, AMD3100 (240µg/kg) or placebo will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on each day of apheresis. G-CSF will be administered in the morning and approximately 1 hour prior to apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses until a minimum of 2x10^6 CD34+ cells/kg or greater than or equal to 5x10^6 CD34+cells/kg are collected. More cells may be collected, if done within the 7 aphereses. Patients who are to receive a tandem transplant will undergo a minimum of 2 and maximum of 7 aphereses until a minimum of 4x10^6 CD34+ cells/kg are collected. Aphereses should be performed on consecutive days (including weekend days)
The patient will have a peripheral blood (PB) sample collected to measure the number of CD34+ cell in PB at baseline prior to administration of G-CSF, prior to each administration of AMD3100 or placebo and at the initiation of apheresis. In addition, a sample will be obtained from each apheresis product to measure the number of CD34+ cells collected in the apheresis product.
Patients who fail to collect greater than or equal to 0.8x10^6 CD34+ cells/kg in 7 aphereses will be offered a rescue arm giving AMD3100 plus G-CSF.
Patients will undergo their ablative chemotherapy before transplantation. Patients will then be transplanted. The success of the transplantation will be evaluated. Graft durability will be evaluated to 12 months post-transplant. In the event that a sufficient number of cells for transplantation are not obtained from the collections, cells may be retained, pooled, and transplanted at a later date at the Investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMD3100 added to a G-CSF Mobilisation regimen | Experimental | Drug: Plerixafor (AMD3100)AMD3100 added to a G-CSF Mobilisation regimen |
| G-CSF plus placebo | Active comparator | Drug: Can be any registered nonpegylated form of G-CSFG-CSF plus placebo |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Eligible to undergo autologous transplantation.
- Diagnosis of NHL, HD or MM [patients with plasma cell leukemia or other leukemias including chronic lymphocytic leukemia (CLL), are excluded].
- In the last collection attempt prior to entry into this trial, the patient has failed to collect 0.8x10^6 cells/kg in at least 2 apheresis sessions or 2x10^6 cells/kg in 4 apheresis sessions using a mobilization regimen of chemotherapy, with or without G-CSF.
- A minimum of a 7 day interval between last collection attempt and randomization.
- Cardiac, pulmonary and renal function deemed clinically adequate to be able to undergo mobilization and transplant.
Key exclusion criteria (12 listed)
- A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications.
- A residual acute medical condition resulting from prior chemotherapy.
- Received thalidomide, dexamethasone or corticosteroids, Rituxan® and Velcade® within 7 days prior to randomization.
- Brain metastases or carcinomatous meningitis.
- Active acute or chronic infection or anti-infective therapy within 1 week prior to randomization.
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 |
|---|---|---|
| Plerixafor (AMD3100)0.24mg/kg SC for 2 to 7 days. | Drug | AMD3100 added to a G-CSF Mobilisation regimen |
| Can be any registered nonpegylated form of G-CSF10mcg/kg SC for 4 days followed by an additional 2 to 7 days. | Drug | G-CSF plus placebo |
Primary outcome
To determine if patients reach a target of ≥ 2x10^6 CD34+ cells/kg within 2 days of apheresis in Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) patients who are proven poor mobilizer.
Time frame: after last apheresis
8 secondary outcomes
To examine and compare the safety of both mobilization regimens, G-CSF plus AMD3100(240µg/kg) and G-CSF plus placebo in NHL, MM and HD patients.
Time frame: After each dose of AMD3100
To measure the daily and total number of CD34+ cells harvested during apheresis.
Time frame: After each dose of AMD3100
To measure the number of days of apheresis needed to harvest ≥ 2x10^6 CD34+ cells/kg.
Time frame: After each dose of AMD3100 transplantation and engraftment
To measure the number of days of apheresis needed to harvest ≥ 5x10^6 CD34+ cells/kg.
Time frame: After each dose of AMD3100, transplantation and engraftment
To determine the times of platelet (PLT) and polymorphonuclear leukocyte (PMN) engraftment.
Time frame: After each dose of AMD3100, transplantation and engraftment
To evaluate the durability of engraftment.
Time frame: After each dose of AMD3100, transplantation and engraftment
To determine if patient reach the Optimum Target of 5x10^6 CD34+ cells/kg within 4 days of apheresis.
Time frame: After each dose of AMD3100, transplantation and engraftment
To determine if NHL tumor cells are mobilized after either G-CSF mobilization of AMD3100 administration
Time frame: After G-CSF mobilization period and after each dose of 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 Feb 2014.
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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
5 sites 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 (AMD3100) and Can be any registered nonpegylated form of G-CSF in people with Lymphoma and Non Hodgkin's Lymphoma, run by Genzyme, a Sanofi Company at 5 sites in Germany.
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 15 inclusion and 12 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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 determine if patients reach a target of ≥ 2x10^6 CD34+ cells/kg within 2 days of apheresis in Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) patients who are proven poor mobilizer. (time frame: after last apheresis). 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 Feb 2014.