Lymphoma, Non-HodgkinPhase 2NCT00322387

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

A Phase 2 study testing G-CSF and plerixafor in people with Lymphoma, Non-Hodgkin and Multiple Myeloma, run by Genzyme, a Sanofi Company at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Lymphoma, Non-Hodgkin, Multiple Myeloma
What is being tested?: G-CSF and plerixafor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 5 sitesUnited States
Study dates: Apr 2004to Jul 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

MM in first partial response/complete response, first relapse, or second partial/complete response
NHL in first or second partial or complete remission
NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
MM patients who have stable disease with < 40% bone marrow involvement
No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Show all 9Show fewer

White blood cell count (WBC) >3.0 x 10^9/L
Absolute neutrophil count >1.5 x 10^9/L
Platelet count >100 x 10^9/L

Who cannot join

Brain metastases or carcinomatous meningitis
Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
Acute Infection

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Indiana Blood and Marrow Transplantation
Beech Grove, Indiana
City of Hope National Medical Center
Duarte, California
Oregon Health and Science University
Portland, Oregon
University of Rochester Medical Center
Rochester, New York
Fred Hutchinson Cancer Research Center
Seattle, Washington

Other trials in United States

About this study

Official title: Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Read the detailed description

An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.

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: Lymphoma, Non-Hodgkin, Multiple Myeloma
Being tested: G-CSF and plerixafor
Keywords: Non-Hodgkin's Lymphoma, Multiple Myeloma, Stem cell mobilization
Medical subject headings: Lymphoma, Non-Hodgkin, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

G-CSF and plerixaforDrug
Also called Mozobil, AMD3100
G-CSF and plerixafor were administered as described in the treatment arms.

Study groups in NCT00322387
Study group	Role	What they receive
Plerixafor PM	Experimental	Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications. Receives: Drug: G-CSF and plerixafor
Plerixafor AM	Experimental	Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications. Receives: Drug: G-CSF and plerixafor
Low CD34+ Count/ Plerixafor PM	Experimental	Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications. Receives: Drug: G-CSF and plerixafor
Plerixafor After Chemo	Experimental	This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications. Receives: Drug: G-CSF and plerixafor

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. 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: 13 months

Secondary outcomes (2)

Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Measured: Days 4-5 (first dose of plerixafor to apheresis)
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2004Jul 2006

First posted5 May 2006 (estimated)
Study startApr 2004
Primary completionJul 2006
Study completionJul 2006

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lymphoma, Non-HodgkinStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00322387
Sponsor's protocol ID: AMD3100-2104
Status last verified: Feb 2014
First submitted: 4 May 2006
Last updated: 13 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory trial in patients with multiple myeloma and non-Hodgkin's lymphoma undergoing stem cell mobilization. Bone Marrow Transplant. 2010 Jan;45(1):39-47. doi: 10.1038/bmt.2009.119. Epub 2009 Jun 1.
PubMed 19483760

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF
ClinicalTrials.gov ID: NCT00322387
Acronym / sponsor ID: AMD3100-2104
Conditions: Lymphoma, Non-Hodgkin, Multiple Myeloma
Keywords: Non-Hodgkin's Lymphoma, Multiple Myeloma, Stem cell mobilization
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 5 May 2006 (estimated)
Results: Posted 14 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Plerixafor PM	Experimental	Drug: G-CSF and plerixaforParticipants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications.
Plerixafor AM	Experimental	Drug: G-CSF and plerixaforParticipants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications.
Low CD34+ Count/ Plerixafor PM	Experimental	Drug: G-CSF and plerixaforParticipants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications.
Plerixafor After Chemo	Experimental	Drug: G-CSF and plerixaforThis investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

MM in first partial response/complete response, first relapse, or second partial/complete response
NHL in first or second partial or complete remission
NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
MM patients who have stable disease with < 40% bone marrow involvement
No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)

Key exclusion criteria (4 listed)

Brain metastases or carcinomatous meningitis
Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
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
G-CSF and plerixaforAlso: Mozobil, AMD3100G-CSF and plerixafor were administered as described in the treatment arms.	Drug	Low CD34+ Count/ Plerixafor PM, Plerixafor AM, Plerixafor After Chemo, Plerixafor PM

Primary outcome

Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Time frame: 13 months
Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. 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.

2 secondary outcomes

Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Time frame: Days 4-5 (first dose of plerixafor to apheresis)
Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant
Time frame: 2 months

Results and safety

Results posted to the registry on 14 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Hodgkin's Lymphoma (NHL)	14	14
Multiple Myeloma (MM)	26	25

Primary outcome: Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant

Time frame: 13 months. Number. Unit: participants

Measure	Non-Hodgkin's Lymphoma (NHL): Plerixafor PM n = 7	Non-Hodgkin's Lymphoma (NHL): Plerixafor AM n = 6	Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo n = 1	Multiple Myeloma (MM): Plerixafor PM n = 12	Multiple Myeloma (MM): Plerixafor AM n = 9	Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM n = 1	Multiple Myeloma (MM): Plerixafor After Chemo n = 4	All Participants n = 40
Participants reporting ≥ 1 Adverse Event	7	6	1	12	9	1	3	39
AE Severity (Mild)	3	3	0	2	2	0	0	10
AE Severity (Moderate)	2	1	1	6	3	0	2	15
AE Severity (Severe)	2	2	0	4	4	1	1	14
AE Severity (Life Threatening)	1	1	0	2	3	0	0	7
AE Relationship to Drug (Not related)	0	5	0	0	2	0	2	9
AE Relationship to Drug (Probably not related)	3	0	0	3	0	0	0	6
AE Relationship to Drug (Possibly related)	1	0	0	3	5	0	0	9

Population analysed: Safety population who received at least one dose of plerixafor.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment Period includes the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for the first transplant. This period includes G-CSF administration, the plerixafor dose, and the rest period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Hodgkin's Lymphoma (NHL): Plerixafor PM	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor AM	0 of 6 (0%)	6 of 6 (100%)	Not reported
Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo	0 of 1 (0%)	1 of 1 (100%)	Not reported
Multiple Myeloma (MM): Plerixafor PM	2 of 12 (16.7%)	12 of 12 (100%)	Not reported
Multiple Myeloma (MM): Plerixafor AM	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM	0 of 1 (0%)	1 of 1 (100%)	Not reported
Multiple Myeloma (MM): Plerixafor After Chemo	1 of 4 (25%)	2 of 4 (50%)	Not reported

Limitations and caveats (from the sponsor): The number and complexity of the cohorts make generalizations regarding the data problematic. Each cohort was small, and mobilizing and high-dose conditioning regimens varied across sites. AEs may include residual effects of chemotherapy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19483760Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory trial in patients with multiple myeloma and non-Hodgkin's lymphoma undergoing stem cell mobilization. Bone Marrow Transplant. 2010 Jan;45(1):39-47. doi: 10.1038/bmt.2009.119. Epub 2009 Jun 1.

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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 G-CSF and plerixafor in people with Lymphoma, Non-Hodgkin and Multiple Myeloma, run by Genzyme, a Sanofi Company at 5 sites 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 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 13 Mar 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 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 14 Jul 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?

Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant (time frame: 13 months). 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 NCT00322387, which also lists 1 linked publication.

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 13 Mar 2014.