Multiple MyelomaPhase 2NCT02098109

Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

A Phase 2 study testing XM02 Filgrastim, Filgrastim and Apheresis in people with Multiple Myeloma and Lymphoma, Non-Hodgkin, run by Washington University School of Medicine at 1 site 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 years and older
Conditions the study is for: Multiple Myeloma, Lymphoma, Non-Hodgkin
What is being tested?: XM02 Filgrastim, Filgrastim 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: 100 participants
Where: 1 siteUnited States
Study dates: 20 Aug 2014to 18 Sep 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 18 years of age
Diagnosis of multiple myeloma or non-Hodgkin lymphoma
Eligible for autologous transplantation
Adequate bone marrow function as defined as:
White Blood Cell Count ≥ 3.0x109/L
Absolute Neutrophil Count ≥ 1.5x109/L

Show all 11Show fewer

Platelet Count ≥ 100x109/L
Able to understand and willing to sign an IRB-approved informed consent document
Surgically or biologically sterile or willing to practice acceptable birth control, as follows:
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day 1 of study treatment. Women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence
Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence

Who cannot join

Previous autologous stem cell collection
Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products
Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Randomized, Open Label, Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) When Administered in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

Read the detailed description

This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor. The FDA has determined that Granix is biosimilar to Neupogen, which means that they are similar in terms of quality, safety, and efficacy; however, Granix has not been tested in the context of stem cell mobilization to see how its effectiveness compares to that of Neupogen

Conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin
Being tested: XM02 Filgrastim, Filgrastim, Apheresis, Plerixafor, Stem Cell Transplant
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.

XM02 FilgrastimDrug
Also called Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix
FilgrastimDrug
Also called Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF
ApheresisProcedure or surgery
PlerixaforDrug
Also called Mozobil, AMD3100
Stem Cell TransplantProcedure or surgery
Also called ASCT

Study groups in NCT02098109
Study group	Role	What they receive
XM02 Filgrastim (Granix) and Plerixafor	Experimental	* XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) * Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) * Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize > 2.0 x 10^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up. Receives: Drug: XM02 Filgrastim; Procedure: Apheresis; Drug: Plerixafor; Procedure: Stem Cell Transplant
Filgrastim (Neupogen) and Plerixafor	Active comparator	* Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) * Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) * Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize > 2.0 x 10^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up. Receives: Drug: Filgrastim; Procedure: Apheresis; Drug: Plerixafor; Procedure: Stem Cell Transplant

What is being measured

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

Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Measured: Day 5

Secondary outcomes (8)

Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
-Adverse events will be assessed using CTCAE version 4.0
Measured: Up to 20 days after last apheresis (Day 25-Day 28)
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.
Measured: Up to Day 30 post-infusion
Comparison of the Time to Platelet Engraftment Between the Two Arms
Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.
Measured: Up to Day 100
Comparison of the Readmission Rate Between the Two Arms
Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse
Measured: Up to Day 100
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Measured: Up to Day 8 (total collection)
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Measured: Up to Day 8 (total collection)
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
Measured: Day 5
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
Measured: Day 5

Timeline

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

20 Aug 201418 Sep 2016

First posted27 Mar 2014 (estimated)
Study start20 Aug 2014
Primary completion10 Jun 2016
Study completion18 Sep 2016

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 Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02098109
Sponsor's protocol ID: 201403068
Status last verified: Jul 2017
First submitted: 20 Mar 2014
Last updated: 18 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bhamidipati PK, Fiala MA, Grossman BJ, DiPersio JF, Stockerl-Goldstein K, Gao F, Uy GL, Westervelt P, Schroeder MA, Cashen AF, Abboud CN, Vij R. Results of a Prospective Randomized, Open-Label, Noninferiority Study of Tbo-Filgrastim (Granix) versus Filgrastim (Neupogen) in Combination with Plerixafor for Autologous Stem Cell Mobilization in Patients with Multiple Myeloma and Non-Hodgkin Lymphoma. Biol Blood Marrow Transplant. 2017 Dec;23(12):2065-2069. doi: 10.1016/j.bbmt.2017.07.023. Epub 2017 Aug 7.
PubMed 28797783

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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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) When Administered in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT02098109
Acronym / sponsor ID: 201403068
Conditions: Multiple Myeloma, Lymphoma, Non-Hodgkin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 20 Aug 2014 (actual)
Primary completion: 10 Jun 2016 (actual)
Study completion: 18 Sep 2016 (actual)
First posted: 27 Mar 2014 (estimated)
Results: Posted 18 Jul 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
XM02 Filgrastim (Granix) and Plerixafor	Experimental	Drug: XM02 Filgrastim, Procedure: Apheresis, Drug: Plerixafor, Procedure: Stem Cell Transplant* XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) * Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) * Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize > 2.0 x 10^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.
Filgrastim (Neupogen) and Plerixafor	Active comparator	Drug: Filgrastim, Procedure: Apheresis, Drug: Plerixafor, Procedure: Stem Cell Transplant* Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) * Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) * Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met) * Patients who undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be followed through Day +100 post-infusion (+/- 30 days) to assess for transplant outcomes (neutrophil and platelet engraftment, and readmission rate). Patients who successfully mobilize > 2.0 x 10^6 CD34+ cells/kg but do not undergo infusion of the mobilized PBSC product within 6 months of the last apheresis procedure will be discontinued from follow-up.

Who may qualify

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

Key inclusion criteria (11 listed)

At least 18 years of age
Diagnosis of multiple myeloma or non-Hodgkin lymphoma
Eligible for autologous transplantation
Adequate bone marrow function as defined as:
Able to understand and willing to sign an IRB-approved informed consent document

Key exclusion criteria (3 listed)

Previous autologous stem cell collection
Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products
Pregnant or breastfeeding

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
XM02 FilgrastimAlso: Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix	Drug	XM02 Filgrastim (Granix) and Plerixafor
FilgrastimAlso: Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF	Drug	Filgrastim (Neupogen) and Plerixafor
Apheresis	Procedure or surgery	Filgrastim (Neupogen) and Plerixafor, XM02 Filgrastim (Granix) and Plerixafor
PlerixaforAlso: Mozobil, AMD3100	Drug	Filgrastim (Neupogen) and Plerixafor, XM02 Filgrastim (Granix) and Plerixafor
Stem Cell TransplantAlso: ASCT	Procedure or surgery	Filgrastim (Neupogen) and Plerixafor, XM02 Filgrastim (Granix) and Plerixafor

Primary outcome

Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms
Time frame: Day 5

8 secondary outcomes

Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
Time frame: Up to 20 days after last apheresis (Day 25-Day 28)
Comparison of the Time to Neutrophil Engraftment Between the Two Arms
Time frame: Up to Day 30 post-infusion
Comparison of the Time to Platelet Engraftment Between the Two Arms
Time frame: Up to Day 100
Comparison of the Readmission Rate Between the Two Arms
Time frame: Up to Day 100
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Time frame: Up to Day 8 (total collection)
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms
Time frame: Up to Day 8 (total collection)
Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
Time frame: Day 5
Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms
Time frame: Day 5

Results and safety

Results posted to the registry on 18 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XM02 Filgrastim (Granix) and Plerixafor	49	46
Filgrastim (Neupogen) and Plerixafor	51	51

Primary outcome: Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms

Time frame: Day 5. Mean (Standard Deviation). Unit: cells/kg

Measure	XM02 Filgrastim (Granix) and Plerixafor n = 46	Filgrastim (Neupogen) and Plerixafor n = 51
Value	11.6 (6.7)	10.0 (6.8)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XM02 Filgrastim (Granix) and Plerixafor	2 of 46 (4.3%)	45 of 46 (97.8%)	Not reported
Filgrastim (Neupogen) and Plerixafor	3 of 51 (5.9%)	50 of 51 (98%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28797783Bhamidipati PK, Fiala MA, Grossman BJ, DiPersio JF, Stockerl-Goldstein K, Gao F, Uy GL, Westervelt P, Schroeder MA, Cashen AF, Abboud CN, Vij R. Results of a Prospective Randomized, Open-Label, Noninferiority Study of Tbo-Filgrastim (Granix) versus Filgrastim (Neupogen) in Combination with Plerixafor for Autologous Stem Cell Mobilization in Patients with Multiple Myeloma and Non-Hodgkin Lymphoma. Biol Blood Marrow Transplant. 2017 Dec;23(12):2065-2069. doi: 10.1016/j.bbmt.2017.07.023. Epub 2017 Aug 7.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
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Active, not recruitingPhase 1/2
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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.

Camille Abboud, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 3 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 18 Jul 2017. 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 18 Jul 2017). 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?

Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms (time frame: Day 5). 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 NCT02098109, 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 18 Jul 2017.