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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-20

Study Completion Date

2016-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

NCT01097057

Non-Hodgkin Lymphoma

COMPLETED PHASE2

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

NCT00103610

Lymphoma, Non-Hodgkin

COMPLETED PHASE3

Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)

NCT00096460

Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma +1 more

TERMINATED PHASE2/PHASE3

Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma

NCT01408043

Adult Acute Lymphoblastic Leukemia in Remission Adult Grade III Lymphomatoid Granulomatosis Adult Nasal Type Extranodal NK/T-cell Lymphoma +31 more

TERMINATED NA

This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant.

NCT00720603

Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma

NO_LONGER_AVAILABLE

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma Lymphoma, Non-Hodgkin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

XM02 Filgrastim (Granix) and Plerixafor

* 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.

Group Type EXPERIMENTAL

XM02 Filgrastim

Intervention Type DRUG

Apheresis

Intervention Type PROCEDURE

Plerixafor

Intervention Type DRUG

Stem Cell Transplant

Intervention Type PROCEDURE

Filgrastim (Neupogen) and Plerixafor

* 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.

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

Apheresis

Intervention Type PROCEDURE

Plerixafor

Intervention Type DRUG

Stem Cell Transplant

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

XM02 Filgrastim

Intervention Type DRUG

Filgrastim

Intervention Type DRUG

Apheresis

Intervention Type PROCEDURE

Plerixafor

Intervention Type DRUG

Stem Cell Transplant

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Granulocyte Colony-Stimulating Factor, G-CSF, Recombinant Methionyl Human G-CSF, tbo-filgrastim, Granix Neulasta®, Neupogen®, Granulocyte Colony-Stimulating Factor, G-CSF Mozobil, AMD3100 ASCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No