Multiple MyelomaPhase 2NCT00067639
Pegfilgrastim (Neulasta) for Stem Cell Mobilization in Patients With Multiple Myeloma
A Phase 2 study testing Pegfilgrastim (Neulasta) and Apheresis in people with Multiple Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Pegfilgrastim (Neulasta) and Apheresis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Apr 2007
- 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
- 1. Age 18 years or older
- Patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation and PBPC cell collection without chemopriming.
- Zubrod performance status < 3 (Appendix E)
- Serum bilirubin < 1.5 times the upper limit of normal, serum SGOT and SGPT < 2 times the upper limit of normal, serum creatinine < 2.0 mg/dl
- WBC > 3,500/ul
- Platelet count > 100,000/ul prior to first apheresis procedure
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- Patients should not have received prior chemotherapy. Only patients who have been treated with thalidomide, bortezomib, +/- dexamethasone will be eligible.
- Sufficient peripheral venous access or central venous catheter
- Informed consent
Who cannot join
- Serious intercurrent medical illness
- History of bleeding disorders (except patients with treated, myeloma related bleeding disorders)
- Untreated hypercoagulation abnormalities
- Patients with prior history of pulmonary embolism, deep venous thrombosis requiring anticoagulant therapy, or placement of a venous filter.
- Untreated symptomatic cardiac disease defined as left ventricular EF of <40% and NYHA functional class of > II (Appendix F)
- Uncontrolled infection defined as fever or antibiotics within 72 hours of registration.
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- History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
- Palpable splenomegaly or craniocaudal spleen length greater than 12 cms
- Pregnancy
- Use of aspirin, ibuprofen containing products within 7 days of enrollment
- History of uncontrolled autoimmune disorder
- Sickle cell trait/sickle cell disease
- Women who are lactating or breast feeding
- 14. Patients with abnormal cytogenetics that may be secondary to myelodysplasia (-5, -7 and 11q23 abnormalities) will be excluded
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pegfilgrastim (Neulasta) for Mobilization of Peripheral Blood Progenitor Cells (PBPC) in Patients With Multiple Myeloma
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Other advantages include faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the amount of tumor contamination and technical ability to obtain stem cells from patients previously considered unharvestable because of marrow fibrosis or because of prior radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell mobilization based on its safety profile and the positive experience in granulocyte donors however, the number of circulating CD34+ cells does not occur until the third day after starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of neutrophil precursors and enhances the functions of mature neutrophils in the same manner as filgrastim. Data form normal volunteers and in studies of patients with cancer have shown prolonged serum levels of the cytokine, with "self-regulation" of pegfilgrastim levels as a function of the neutrophil count. This confers a therapeutic advantage in clinical settings by allowing a less frequent dosing.
Read the detailed description
Stem cells are a special type of blood cell, which are able to grow and divide. Stem cells are given to patients after high dose chemotherapy to help restore blood production and immunity. For an autologous stem cell transplant, stem cells are collected from a patient before they have chemotherapy, then they are "transplanted" back to the same patient after treatment. Circulating blood contains a very small number of stem cells. It is often necessary to use the drug NeupogenTM, by injection under the skin twice a day for three days, before stem cells are collected to help move the stem cells out of the bone marrow and into the circulating blood. When the stem cells are in the blood, they can be collected more easily. The study drug pegfilgrastim is very similar to NeupogenTM, however, it is longer lasting. Therefore, treatment can be given as a single injection rather than several injections over many days.
For this study, you will receive a single injection of pegfilgrastim under the skin. Starting 3 days after the injection, you will have blood tests (1-2 tablespoons) once a day. These blood tests will be used to learn if there are enough stem cells circulating in the blood to start the collection procedure and for tests to check for any side effects of the drug. These once a day blood tests will continue up to 10 days after the completion of the stem cell collection procedure. When the stem cell count reaches a certain level (usually 4 or 5 days after the injection), stem cell collection will be started and done once a day until enough cells have been collected for transplantation.
Before the collection starts, you will have blood (1-2 tablespoons) and urine samples collected for routine tests. You will also have a chest x-ray and an electrocardiogram (ECG - a test that measures the electrical activity of the heart). These tests are being done to make sure you can handle the collection process. You will then have a central venous line (CVL) placed. For this procedure, you will have a catheter (small flexible tube) placed in a large vein under the collar bone. The CVL will be used to collect the stem cells.
You will have your stem cells collected by a procedure called apheresis. This procedure is similar to donating platelets in a blood bank. In this process blood is collected through the CVL and is passed through a cell separator machine. White cells (that contain the stem cells) are collected and frozen and the remaining blood is given back to you. During the apheresis procedure blood is kept from clotting by a continuous injection of ACD-A (sodium citrate solution). This may cause some loss of calcium from the blood. To help with this side effect, a calcium containing solution is continuously injected during the process of stem cell collection. The procedure takes around 4-6 hours. If sufficient numbers of stem cells are not collected in a single procedure, the procedure is repeated until the required number of stem cells can be collected. The maximum number of procedures will be 5. If enough stem cells cannot be collected after 5 procedures you will be taken off the study and your doctor will discuss other treatment options with you.
The stem cells that are collected will be "transplanted" back to you after you have high-dose chemotherapy as part of your standard care.
This is an investigational study. Pegfilgrastim is FDA approved and is commercially available. It is approved to increase white blood cell count after chemotherapy. However, its use in the collection of stem cells for transplantation is experimental. Up to 48 participants will take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Multiple Myeloma
- Being tested
- Pegfilgrastim (Neulasta), Apheresis
- Keywords
- Multiple Myeloma, PBSC mobilization, Pegfilgrastim, Neulasta, PEG-G-CSF
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegfilgrastim (Neulasta)Drug
Also called PEG-G-CSF
12 mg single injection of pegfilgrastim under the skin prior to apheresis.
ApheresisProcedure or surgery
Also called Leukapheresis
Collection of stem cells, repeated daily until target stem cell dose reached, maximum of 5 procedures.
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim + Apheresis | Experimental | 12 mg Pegfilgrastim as subcutaneous injection on day 1 + Apheresis daily till target stem cell dose reached. Receives: Drug: Pegfilgrastim (Neulasta); Procedure: Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of pegfilgrastim in mobilizing progenitor cells
Measured: Baseline to 10 days after pegfilgrastim injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2003 (estimated)
- Study startDec 2003
- Primary completionApr 2007
- Study completionApr 2007
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Chitra Hosing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067639
- Sponsor's protocol ID
- ID03-0164
- Status last verified
- Jul 2012
- First submitted
- 25 Aug 2003
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegfilgrastim (Neulasta) for Mobilization of Peripheral Blood Progenitor Cells (PBPC) in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00067639
- Acronym / sponsor ID
- ID03-0164
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, PBSC mobilization, Pegfilgrastim, Neulasta, PEG-G-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Dec 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 26 Aug 2003 (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.
In recent years PBPC have replaced bone marrow as the source of hematopoietic stem cells for autologous transplantation. One of the cited advantages of this procedure is the avoidance of bone marrow harvest, which frequently requires general anesthesia. Other advantages include faster neutrophil and platelet engraftment times, faster immune recovery, decrease in the amount of tumor contamination and technical ability to obtain stem cells from patients previously considered unharvestable because of marrow fibrosis or because of prior radiotherapy to the pelvis. Filgrastim has emerged as the preferred cytokine for stem cell mobilization based on its safety profile and the positive experience in granulocyte donors however, the number of circulating CD34+ cells does not occur until the third day after starting filgrastim injections. Pegfilgrastim stimulates the production and maturation of neutrophil precursors and enhances the functions of mature neutrophils in the same manner as filgrastim. Data form normal volunteers and in studies of patients with cancer have shown prolonged serum levels of the cytokine, with "self-regulation" of pegfilgrastim levels as a function of the neutrophil count. This confers a therapeutic advantage in clinical settings by allowing a less frequent dosing.
Detailed description
Stem cells are a special type of blood cell, which are able to grow and divide. Stem cells are given to patients after high dose chemotherapy to help restore blood production and immunity. For an autologous stem cell transplant, stem cells are collected from a patient before they have chemotherapy, then they are "transplanted" back to the same patient after treatment. Circulating blood contains a very small number of stem cells. It is often necessary to use the drug NeupogenTM, by injection under the skin twice a day for three days, before stem cells are collected to help move the stem cells out of the bone marrow and into the circulating blood. When the stem cells are in the blood, they can be collected more easily. The study drug pegfilgrastim is very similar to NeupogenTM, however, it is longer lasting. Therefore, treatment can be given as a single injection rather than several injections over many days.
For this study, you will receive a single injection of pegfilgrastim under the skin. Starting 3 days after the injection, you will have blood tests (1-2 tablespoons) once a day. These blood tests will be used to learn if there are enough stem cells circulating in the blood to start the collection procedure and for tests to check for any side effects of the drug. These once a day blood tests will continue up to 10 days after the completion of the stem cell collection procedure. When the stem cell count reaches a certain level (usually 4 or 5 days after the injection), stem cell collection will be started and done once a day until enough cells have been collected for transplantation.
Before the collection starts, you will have blood (1-2 tablespoons) and urine samples collected for routine tests. You will also have a chest x-ray and an electrocardiogram (ECG - a test that measures the electrical activity of the heart). These tests are being done to make sure you can handle the collection process. You will then have a central venous line (CVL) placed. For this procedure, you will have a catheter (small flexible tube) placed in a large vein under the collar bone. The CVL will be used to collect the stem cells.
You will have your stem cells collected by a procedure called apheresis. This procedure is similar to donating platelets in a blood bank. In this process blood is collected through the CVL and is passed through a cell separator machine. White cells (that contain the stem cells) are collected and frozen and the remaining blood is given back to you. During the apheresis procedure blood is kept from clotting by a continuous injection of ACD-A (sodium citrate solution). This may cause some loss of calcium from the blood. To help with this side effect, a calcium containing solution is continuously injected during the process of stem cell collection. The procedure takes around 4-6 hours. If sufficient numbers of stem cells are not collected in a single procedure, the procedure is repeated until the required number of stem cells can be collected. The maximum number of procedures will be 5. If enough stem cells cannot be collected after 5 procedures you will be taken off the study and your doctor will discuss other treatment options with you.
The stem cells that are collected will be "transplanted" back to you after you have high-dose chemotherapy as part of your standard care.
This is an investigational study. Pegfilgrastim is FDA approved and is commercially available. It is approved to increase white blood cell count after chemotherapy. However, its use in the collection of stem cells for transplantation is experimental. Up to 48 participants will take part in this study. All will be enrolled at UTMDACC.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim + Apheresis | Experimental | Drug: Pegfilgrastim (Neulasta), Procedure: Apheresis12 mg Pegfilgrastim as subcutaneous injection on day 1 + Apheresis daily till target stem cell dose reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age 18 years or older
- Patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation and PBPC cell collection without chemopriming.
- Zubrod performance status < 3 (Appendix E)
- Serum bilirubin < 1.5 times the upper limit of normal, serum SGOT and SGPT < 2 times the upper limit of normal, serum creatinine < 2.0 mg/dl
- WBC > 3,500/ul
Key exclusion criteria (15 listed)
- Serious intercurrent medical illness
- History of bleeding disorders (except patients with treated, myeloma related bleeding disorders)
- Untreated hypercoagulation abnormalities
- Patients with prior history of pulmonary embolism, deep venous thrombosis requiring anticoagulant therapy, or placement of a venous filter.
- Untreated symptomatic cardiac disease defined as left ventricular EF of <40% and NYHA functional class of > II (Appendix F)
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 |
|---|---|---|
| Pegfilgrastim (Neulasta)Also: PEG-G-CSF12 mg single injection of pegfilgrastim under the skin prior to apheresis. | Drug | Pegfilgrastim + Apheresis |
| ApheresisAlso: LeukapheresisCollection of stem cells, repeated daily until target stem cell dose reached, maximum of 5 procedures. | Procedure or surgery | Pegfilgrastim + Apheresis |
Primary outcome
Efficacy of pegfilgrastim in mobilizing progenitor cells
Time frame: Baseline to 10 days after pegfilgrastim injection
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 1 Aug 2012.
- UT MD Anderson Cancer Center 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.
Chitra 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?
A Phase 2 study testing Pegfilgrastim (Neulasta) and Apheresis in people with Multiple 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 9 inclusion and 15 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 1 Aug 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.
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?
Efficacy of pegfilgrastim in mobilizing progenitor cells (time frame: Baseline to 10 days after pegfilgrastim injection). 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 Aug 2012.