Lonquek for Autologous Stem Cell Mobilization

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.

Official Title
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Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma

Conditions
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Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Drug: Lonquek


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed multiple myeloma or Hodgkins or non Hodgkin lymphoma at need of autologous stem cell transplantation. Disease must be chemosensitive or stable status to prior therapy before transplant. Age between 18 and 65 years inclusive. ECOG performance status 0, 1 or 2. Written informed consent. Adequate birth control in fertile patients. Exclusion Criteria: Lymphoma patients that did not fulfill the inclusion criteria. Patients with factors predicting poor mobilization including >3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like Melphalan, Fludarabine, >2 courses of Revlimid, age >65 years, platelets counts <100x109/L, WBC<2.5x109/L or WBC > 35x109/L. Previous autologous stem cell transplantation. Inability to tolerate peripheral blood stem cell harvest. Peripheral venous access not possible.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lonquek<br>treatment with Lonquek for autologous stem cell collection | Drug: Lonquek<br>* Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.<br>* Other names: Lipegfilgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilisation success rate | Mobilisation success rate is defined as the mobilisation of a peripheral blood stem cell graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engraftment after transplantation | Time until recovery of blood counts after transplantation | 100 days | 
| Safety | Number of participants with adverse events | 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, multiple myeloma, stem cell mobilization, autologous stem cell transplantation