Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-10 @ 4:39 AM
Study NCT ID:
NCT00599495
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2008-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2008-01-11', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engraftment, chimerism, toxicity, non-relapse mortality', 'timeFrame': 'Follow-up until day +1095'}], 'secondaryOutcomes': [{'measure': 'Evaluation of response/GvHD/ infectious complications/ disease-free survival, Prognostic impact of cytogenetic, Evaluation of incidence and prognostic impact of molecular remission in patients with clinically complete remission.', 'timeFrame': 'Follow-up until day +1095'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hematopoietic Stem Cell Transplantation', 'Multiple Myeloma'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '19912215', 'type': 'RESULT', 'citation': 'Kroger N, Shimoni A, Schilling G, Schwerdtfeger R, Bornhauser M, Nagler A, Zander AR, Heinzelmann M, Brand R, Gahrton G, Morris C, Niederwieser D, de Witte T. Unrelated stem cell transplantation after reduced intensity conditioning for patients with multiple myeloma relapsing after autologous transplantation. Br J Haematol. 2010 Jan;148(2):323-31. doi: 10.1111/j.1365-2141.2009.07984.x. Epub 2009 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.', 'detailedDescription': 'The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support\n* Age 18-60 years\n* ECOG-performance status 0-1\n* Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1)\n\nExclusion Criteria:\n\n* Serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy\n* Severe cardiac failure (ejection fraction \\< 40%)\n* Severe impairment of renal function (Creatinine clearance \\< 50ml/min)\n* Severe impairment of liver function (bilirubine \\> 2 fold of upper limits of normal)\n* Pregnant or lactating women\n* Other major organ or system dysfunctions(GI, neurological, psychiatric dysfunctions that would impair tolerance of chemotherapy or prolonged haematological recovery)\n* Positivity for HIV'}, 'identificationModule': {'nctId': 'NCT00599495', 'briefTitle': 'Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-study', 'orgStudyIdInfo': {'id': 'EBMT MUDRIC-MM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'allogeneic HSCT', 'type': 'PROCEDURE', 'description': 'dose-reduced conditioning regimen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Nicolaus Kroeger, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}