Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-28 @ 7:08 AM
Study NCT ID:
NCT01105403
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study on POL6326 in Stem Cell Mobilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624271', 'term': 'balixafortide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma', 'timeFrame': 'Up to four days', 'description': '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\n\nNumber of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma', 'timeFrame': '2 months'}, {'measure': 'To determine the efficacy of POL6326 in reconstitution of immune system after transplantation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hematopoietic stem cells', 'Mobilisation', 'Autologous transplantation'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.\n2. 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.\n3. Measurable disease, defined by one of the following:\n\n * Serum M protein ≥1.0 g/dL by protein electrophoresis\n * Quantifiable immunoglobulin levels and/or\n * urinary M protein excretion ≥200 mg/24 hours.\n4. All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 2.\n6. Life expectancy of \\>6 months.\n7. Have given their written informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Have non-secretory myeloma and/or plasma cell leukaemia.\n2. 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.\n3. Any other clinically significant medical conditions.\n4. History of cardiac disease NHYA classification ≥3.\n5. Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:\n\n 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.\n6. Pregnant or lactating female patients.\n7. Known history of HIV infection or chronic hepatitis B or C infection.\n8. Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.\n9. Prior radiotherapy to more than 3 vertebrae.\n10. Active serious bacterial or fungal infections; \\>grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).\n11. Receipt of haematopoietic cytokines within 10 days of study drug administration.'}, 'identificationModule': {'nctId': 'NCT01105403', 'briefTitle': 'Exploratory Study on POL6326 in Stem Cell Mobilization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Polyphor Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'POL-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD34+ mobilisation for transplantation', 'interventionNames': ['Drug: POL6326']}], 'interventions': [{'name': 'POL6326', 'type': 'DRUG', 'otherNames': ['not appicable'], 'description': 'IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood', 'armGroupLabels': ['CD34+ mobilisation for transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Department of Internal Medicine V', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Hartmut Goldschmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polyphor Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}