Multiple MyelomaNCT01042717
Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection
A study testing Plerixafor in people with Multiple Myeloma and Non-Hodgkins Lymphoma, run by Shi, Patricia, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Non-Hodgkins Lymphoma
- What is being tested?
- Plerixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2011
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Autologous donors age 18 to 75 years with NHL or MM scheduled to undergo peripheral blood stem cell collection as part of standard clinical care. Biopsy-confirmed diagnosis of NHL or MM is to have been done prior to the first mobilization.
- In first or second CR or PR
- ECOG performance status of 0 or 1
- WBC count greater than 2.5 x 10e9/1
- Absolute PMN count greater than 1.5 x 10e9/1
- PLT count greater than 100 x 10e9/1
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- Serum creatinine less than or equal to 2.2 mg/dl
- SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN)
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
- 4 weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone, and bortezomib are not considered chemotherapy for the purpose of the study)
- Patients of childbearing potential agree to use an approved form of contraception
- Recovered from all acute toxic effects of prior chemotherapy
Who cannot join
- Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications
- Failed previous stem cell collections or collection attempts
- Less than 6 weeks of carmustine prior to the 1st dose of G-CSF
- Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization
- Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization
- Active CNS involvement
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- Active brain metastases or carcinomatous meningitis
- Bone marrow involvement greater than 20 percent
- Received radiation therapy to the pelvis
- Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated
- Received prior radio-immunotherapy with Zevalin or Bexxar
- Fever (temperature greater than 38 C/100.4 F)
- Received bone-seeking radionuclides (e.g., holmium)
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or myelomatous meningitis
- Received thalidomide, dexamethasone and/or Velcade within 7 days prior to the first dose of G-CSF
- Received Revlimid within 3 weeks prior to the first dose of G-CSF
- Received greater than 6 cycles of Revlimid
- Positive pregnancy test or lactating
- Active infection requiring antibiotic treatment
- Abnormal ECG with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
- 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.
- Patients whose apheresis product will be further selected and purified.
- Prior autologous or allogeneic transplant.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai School of Medicine
New York, New York, 10029
Patricia A Shi, MD, 212-241-9237, patricia.shi@mssm.edu
Luis M Isola, MD, 212-241-6021, luis.isola@msnyuhealth.org
About this study
Official title: Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection
The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.
Read the detailed description
The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis. This is a logistical problem, since plerixafor should be administered by a health care provider, given the risk of hypotension with administration. The primary purpose of this study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether the dosing interval can be increased to 16 hours prior to apheresis. Patients will be admitted to a special clinical research center on the 4th day of G-CSF administration, where the peripheral blood CD34+ count will be measured every 2 hours after plerixafor administration at 5 pm until 9 AM the following day, at which time apheresis will commence. The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and effective as plerixafor administration at 11 hours prior to apheresis.
- Conditions
- Multiple Myeloma, Non-Hodgkins Lymphoma
- Being tested
- Plerixafor
- Keywords
- plerixafor, autologous transplantation, hematopoietic stem cell mobilization, multiple myeloma, non-Hodgkins lymphoma
- 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.
PlerixaforDrug
Also called Mozobil
Plerixafor administered at 16 hours prior to apheresis
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor | Experimental | Plerixafor 16 hours Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
Measured: After collection
Secondary outcomes (2)
Median and average neutrophil and platelet engraftment
Measured: After stem cell infusion
Plerixafor-related toxicities
Measured: 1 month after stem cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi, Patricia, M.D.
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Patricia Shi, Shi, Patricia, M.D.
- Investigators
- Patricia A Shi, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042717
- Sponsor's protocol ID
- GCO # 09-0824
- Status last verified
- Sep 2011
- First submitted
- 5 Jan 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Liles WC, Rodger E, Broxmeyer HE, Dehner C, Badel K, Calandra G, Christensen J, Wood B, Price TH, Dale DC. Augmented mobilization and collection of CD34+ hematopoietic cells from normal human volunteers stimulated with granulocyte-colony-stimulating factor by single-dose administration of AMD3100, a CXCR4 antagonist. Transfusion. 2005 Mar;45(3):295-300. doi: 10.1111/j.1537-2995.2005.04222.x.
PubMed 15752146DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.
PubMed 19720922
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection
- ClinicalTrials.gov ID
- NCT01042717
- Acronym / sponsor ID
- GCO # 09-0824
- Conditions
- Multiple Myeloma, Non-Hodgkins Lymphoma
- Keywords
- plerixafor, autologous transplantation, hematopoietic stem cell mobilization, multiple myeloma, non-Hodgkins lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shi, Patricia, M.D.
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 Jan 2010 (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.
The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.
Detailed description
The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis. This is a logistical problem, since plerixafor should be administered by a health care provider, given the risk of hypotension with administration. The primary purpose of this study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether the dosing interval can be increased to 16 hours prior to apheresis. Patients will be admitted to a special clinical research center on the 4th day of G-CSF administration, where the peripheral blood CD34+ count will be measured every 2 hours after plerixafor administration at 5 pm until 9 AM the following day, at which time apheresis will commence. The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and effective as plerixafor administration at 11 hours prior to apheresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plerixafor | Experimental | Drug: PlerixaforPlerixafor 16 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Autologous donors age 18 to 75 years with NHL or MM scheduled to undergo peripheral blood stem cell collection as part of standard clinical care. Biopsy-confirmed diagnosis of NHL or MM is to have been done prior to the first mobilization.
- In first or second CR or PR
- ECOG performance status of 0 or 1
- WBC count greater than 2.5 x 10e9/1
- Absolute PMN count greater than 1.5 x 10e9/1
Key exclusion criteria (24 listed)
- Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications
- Failed previous stem cell collections or collection attempts
- Less than 6 weeks of carmustine prior to the 1st dose of G-CSF
- Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization
- Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization
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: MozobilPlerixafor administered at 16 hours prior to apheresis | Drug | Plerixafor |
Primary outcome
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
Time frame: After collection
2 secondary outcomes
Median and average neutrophil and platelet engraftment
Time frame: After stem cell infusion
Plerixafor-related toxicities
Time frame: 1 month after stem cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
- Background: PubMed 15752146Liles WC, Rodger E, Broxmeyer HE, Dehner C, Badel K, Calandra G, Christensen J, Wood B, Price TH, Dale DC. Augmented mobilization and collection of CD34+ hematopoietic cells from normal human volunteers stimulated with granulocyte-colony-stimulating factor by single-dose administration of AMD3100, a CXCR4 antagonist. Transfusion. 2005 Mar;45(3):295-300. doi: 10.1111/j.1537-2995.2005.04222.x.
- Background: PubMed 19720922DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.
- Related InfoLink 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.
Patricia A Shi, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plerixafor in people with Multiple Myeloma and Non-Hodgkins Lymphoma, run by Shi, Patricia, M.D. 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 24 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: status not confirmed, as of the sponsor's last update on 27 Sep 2011. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection (time frame: After collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042717, which also lists 2 linked publications.
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 27 Sep 2011.