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Mozobil (Plerixafor Subcutaneous) - Summary

 
 



MOZOBIL SUMMARY

Mozobil (plerixafor injection) is a sterile, preservative-free, clear, colorless to pale yellow, isotonic solution for subcutaneous injection.   Plerixafor is hematopoietic stem cell mobilizer.

MozobilTM (plerixafor injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).


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NEWS HIGHLIGHTS

Media Articles Related to Mozobil (Plerixafor Subcutaneous)

Predicting aggressive lymphoma by statistical genetic analysis
Source: Genetics News From Medical News Today [2014.08.27]
Each year, more than one thousand Norwegians develop lymphoma. A statistical genetic analysis can detect when the disease will be aggressive. Thereby, treatment can be initiated in time.

Positive results announced for patients with aggressive non-Hodgkin's lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.08.27]
Phase 1-2a clinical trial highlights 12 of 13 Total Evaluable Patients with Advanced B Cell Malignancies Had Complete Remissions (8 Patients) or Partial Remissions (4 Patients) Resulting in a...

Study: race influences medical treatment offered by doctors in lymphoma patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.08.12]
A new study published in a leading scientific journal has shown race can have a detrimental effect on medical treatment offered by doctors.

Study identifies rational drug combinations that may overcome mantle cell lymphoma resistance to ibrutinib - implications for other blood cancers
Source: MRSA / Drug Resistance News From Medical News Today [2014.07.31]
Genomic analyses of tumor and healthy tissue from patients with mantle cell lymphomas that fail to respond to treatment with the anticancer drug ibrutinib (Imbruvica) or initially respond but then...

Lymphoma Treatment May Harm, Halt Men's Sperm Production
Source: MedicineNet Mens Health Specialty [2014.07.28]
Title: Lymphoma Treatment May Harm, Halt Men's Sperm Production
Category: Health News
Created: 7/25/2014 2:36:00 PM
Last Editorial Review: 7/28/2014 12:00:00 AM

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Published Studies Related to Mozobil (Plerixafor Subcutaneous)

Successful stem cell remobilization using plerixafor (mozobil) plus granulocyte colony-stimulating factor in patients with non-hodgkin lymphoma: results from the plerixafor NHL phase 3 study rescue protocol. [2009.12]
In a phase 3 multicenter, randomized, double-blinded, placebo-controlled study of 298 patients with non-Hodgkin lymphoma (NHL), granulocyte colony-stimulating factor (G-CSF) plus plerixafor increased the proportion of patients who mobilized >or=5 x 10(6) CD34(+) hematopoietic stem cells (HSCs)/kg compared with placebo plus G-CSF (P < .001).

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. [2009.10.01]
PURPOSE: This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients... CONCLUSION: Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.

Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. [2009.06.04]
This phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor (G-CSF) in mobilizing hematopoietic stem cells in patients with multiple myeloma... Plerixafor and G-CSF were well tolerated, and significantly more patients collected the optimal CD34(+) cell/kg target for transplantation earlier compared with G-CSF alone.

Plerixafor: a review of its use in stem-cell mobilization in patients with lymphoma or multiple myeloma. [2011.08.20]
Plerixafor (Mozobil(R)) is a CXCR4 chemokine receptor antagonist that is indicated for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize stem cells to the peripheral blood for collection and subsequent autologous stem-cell transplantation in patients who have non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) [US] and in patients who have lymphoma or MM and are poor mobilizers (EU)...

Identification of prognostic factors for plerixafor-based hematopoietic stem cell mobilization. [2011.07]
The introduction of plerixafor has enabled successful collection of stem cells in the majority of patients with lymphoma or myeloma in whom previous attempts at mobilization have failed. However, a proportion of patients have been shown to be resistant to this mobilization regimen... Patients who are characterized by the above negative features could benefit potentially from further improvement in the mobilization strategy.

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Clinical Trials Related to Mozobil (Plerixafor Subcutaneous)

Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization [Recruiting]
Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.

OBJECTIVES

To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:

- increase the number of patients successfully collected in one day

- increase the number of patients successfully mobilized on first collection attempt

- is cost neutral within a Canadian setting

Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant [Recruiting]
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population.

The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.

Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 kg [Not yet recruiting]
The purpose of this study is to compare the responses to 2 different doses of a drug called plerixafor in subjects with Non-Hodgkins Lymphoma (NHL) who will receive an autologous stem cell transplant.

Time Alteration in Timing of Plerixafor Administration [Recruiting]
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.

The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.

We will also assess the safety of giving plerixafor 17 hours before apheresis.

Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma [Recruiting]
Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in patients with recurrent glioblastoma and has been studied extensively in other types of solid tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers. Information from experiments in laboratories suggests that the combination of plerixafor and bevacizumab may help prevent the growth of gliomas.

Part 1: The investigators are looking for the highest dose of plerixafor that can be given safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination.

Part 2: The investigators are looking to see if plerixafor can get past the blood-brain barrier and into brain tumors. The investigators will also do blood tests to find out how the body uses and breaks down the drug combination.

Part 3: The investigators are looking for for more information re: safety and tolerability of plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination.

more trials >>

Reports of Suspected Mozobil (Plerixafor Subcutaneous) Side Effects

Febrile Neutropenia (30)Nausea (21)Respiratory Failure (15)Pleural Effusion (14)Sepsis (12)Death (11)Hypotension (11)Interstitial Lung Disease (10)Pneumonia (10)Therapeutic Response Decreased (10)more >>


Page last updated: 2014-08-27

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