Exploratory Study on POL6326 in Stem Cell Mobilization

Study Overview
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Brief Summary
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The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation

Official Title
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A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients With Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: POL6326


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon. Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment. Measurable disease, defined by one of the following: Serum M protein ≥1.0 g/dL by protein electrophoresis Quantifiable immunoglobulin levels and/or urinary M protein excretion ≥200 mg/24 hours. All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry. Eastern Cooperative Oncology Group (ECOG) performance status of 2. Life expectancy of >6 months. Have given their written informed consent to participate in the study Exclusion Criteria: Have non-secretory myeloma and/or plasma cell leukaemia. History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma. Any other clinically significant medical conditions. History of cardiac disease NHYA classification ≥3. Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations: Haemoglobin <9.0 g/L. Absolute neutrophil count <1500/µL. Platelet count <50000/µL. Total bilirubin >1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) and alkaline phosphatase (AP) >2.5 x ULN. Amylase and lipase >1.5 x ULN. Serum creatinine >2.0 x ULN. Prothrombin time (PT) and activated partial thrombo-plastin time (aPTT) >1.5 x ULN. Pregnant or lactating female patients. Known history of HIV infection or chronic hepatitis B or C infection. Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration. Prior radiotherapy to more than 3 vertebrae. Active serious bacterial or fungal infections; >grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Receipt of haematopoietic cytokines within 10 days of study drug administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: CD34+ mobilisation for transplantation<br> | Drug: POL6326<br>* IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood<br>* Other names: not appicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma | Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW) | Up to four days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma |  | 2 months | 
| To determine the efficacy of POL6326 in reconstitution of immune system after transplantation |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic stem cells, Mobilisation, Autologous transplantation