Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-01 @ 1:38 PM
Study NCT ID:
NCT00352703
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2006-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051523', 'term': 'Fibroblast Growth Factor 7'}], 'ancestors': [{'id': 'D005346', 'term': 'Fibroblast Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-31', 'studyFirstSubmitDate': '2006-07-13', 'studyFirstSubmitQcDate': '2006-07-14', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).', 'timeFrame': 'Up to 40 days', 'description': 'The study consisted of a screening period of up to 42 days to determine subject eligibility, followed by a treatment period of a maximum of 40 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral mucositis', "Non-Hodgkin's lymphoma (NHL)", 'conditioning chemotherapy', 'autologous PBSCT', 'multiple myeloma (MM)', 'Melphalan'], 'conditions': ["Non-Hodgkin's Lymphoma", 'Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.kepivance.com/', 'label': 'FDA-approved Drug Labeling'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT\n* ≥Age 18 years\n* ECOG performance status \\<= 2. In the MM group, ECOG status \\>2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)\n* Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Minimum of 1.5 x 10\\^6 CD34+ cells/kg for autologous transplantation\n* Adequate haematological function (ANC ≥ 1.5 x 10\\^9/L and platelet count ≥ 100 x 10\\^9/L)\n* Serum creatinine \\<= 2.0 mg/dL\n* Total bilirubin \\<= 2 mg/dL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\<= 4.0 x IULN\n* Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment\n* Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria:\n* History of or concurrent cancer other than NHL or MM\n* Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants\n* Oral abnormalities defined as baseline oral assessment of WHO grade \\>0\n* Other investigational procedures are excluded\n* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)\n* Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding\n* Subject is not using adequate contraceptive precautions\n* Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products\n* Subject has previously been treated on this study or with other keratinocyte growth factors\n* Unwilling or unable to complete the patient-reported outcome questionnaires\n* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures."}, 'identificationModule': {'nctId': 'NCT00352703', 'briefTitle': 'PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': "An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation", 'orgStudyIdInfo': {'id': '20050100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kepivance (palifermin) 60 μg/kg/day IV', 'description': '60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation.', 'interventionNames': ['Drug: Kepivance (Palifermin)']}], 'interventions': [{'name': 'Kepivance (Palifermin)', 'type': 'DRUG', 'armGroupLabels': ['Kepivance (palifermin) 60 μg/kg/day IV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biovitrum AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}