Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT03700450
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma
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': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-10-06', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic GvHD', 'timeFrame': '2 years', 'description': 'Chronic GvHD at 2 years after allogeneic SCT'}, {'measure': 'Progression-free survival', 'timeFrame': '2 years', 'description': 'Progression-free survival at 2 years after allogeneic SCT'}], 'secondaryOutcomes': [{'measure': 'Non-relapsed mortality', 'timeFrame': '2 years', 'description': 'Non-relapsed mortality at 2 years after allogeneic SCT'}, {'measure': 'Acute GvHD', 'timeFrame': 'Day +100 after allogeneic SCT', 'description': 'Incidence of acute GvHD on Day +100 after allogeneic SCT'}, {'measure': 'Chronic GvHD', 'timeFrame': '1 and 2 years after allogeneic SCT', 'description': 'Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT'}, {'measure': 'Toxicity of cyclophosphamide', 'timeFrame': 'till 2 years', 'description': 'Toxicity scored according to NCI CTCAE, Version 4.0'}, {'measure': 'Remission rate', 'timeFrame': 'till 2 years', 'description': 'Complete remission rate (including sCR and MRD negativity)'}, {'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'Overall survival at 2 years'}, {'measure': 'Progression-free Survival', 'timeFrame': '2 years', 'description': 'Progression-free survival at 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Without detection of deletion 17p or translocation 4;14;', 'Post Cyclophosphamide', 'GvHD Prophylaxis', 'Allogeneic SCT'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.', 'detailedDescription': 'The present study is a multicenter, prospective Phase II-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group.\n\nIn this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation\n2. Patients age: 18 - 65 years at time of inclusion (female and male)\n3. Performance status ECOG \\< 2\n4. Availability of haploidentical, matched or mismatched related or unrelated donor\n5. Patients understand and voluntarily sign an informed consent\n6. The study population includes female of childbearing potential (FOCP). FOCP have to agree to comply with the applicable contraceptive requirements of the protocol as named below for the duration of the study and 6 months after end of study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization).\n7. Men who are sexually active with FOCP must be instructed to use male contraception (condom) in order to avoid exposure of an existing embryo/fetus. Contraception should be continued until 6 months after end of study.\n\nExclusion Criteria:\n\n1. Severe active infection or other uncontrolled severe conditioning\n2. Severe renal, hepatic, pulmonary or cardiac disease, such as:\n\n * Total bilirubin, SGPT or SGOT \\> 3 times upper the normal level\n * Left ventricular ejection fraction \\< 30 %\n * Creatinine clearance \\< 30 ml/min\n * DLCO \\< 35 % and/or receiving supplementary continuous oxygen\n3. Positive serology for HIV\n4. Pregnant or lactating women (positive serum pregnancy test)\n5. Women of child-bearing potential with unclear contraception\n6. Age \\< 18 and \\> 65 years.\n7. Uncontrolled invasive fungal infection at time of screening (baseline)\n8. Serious psychiatric or psychological disorders\n9. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment'}, 'identificationModule': {'nctId': 'NCT03700450', 'briefTitle': 'Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Cyclophosphamide as Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma. A Phase II Study (Allo-MM-PostCy-Study)', 'orgStudyIdInfo': {'id': 'Allo-MM-PostCy-Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclophosphamid post Tranplant', 'description': 'Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide', 'interventionNames': ['Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan'], 'description': 'Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide', 'armGroupLabels': ['Cyclophosphamid post Tranplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Nicolaus Kröger, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Esteve Pharmaceuticals GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}