Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-26 @ 5:58 AM
Study NCT ID:
NCT01553357
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2012-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007952', 'term': 'Leukemia, Plasma Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2012-03-03', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '4 months', 'description': 'IMWG criteria'}, {'measure': 'Complete remission rate', 'timeFrame': '4 months', 'description': 'IMWG'}, {'measure': 'At least Very good partial remission rate', 'timeFrame': '4 months', 'description': 'IMWG'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '24 months', 'description': 'Median follow-up'}, {'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'Median follow-up'}, {'measure': 'Percentage of patients able to perform stem cell transplantation', 'timeFrame': '12 months', 'description': 'Number of eligible patients reaching stem cell transplantation procedure'}, {'measure': 'Safety', 'timeFrame': '4-8 months, according to protocol', 'description': 'Number of severe/serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Plasma cell leukemia', 'Lenalidomide', 'Dexamethasone', 'Multiple myeloma', 'Bortezomib', 'Stem cell transplantation'], 'conditions': ['Primary Plasma Cell Leukemia']}, 'descriptionModule': {'briefSummary': 'This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).', 'detailedDescription': 'The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL\n* Age \\> 18 years\n* ECOG performance status of 0,1 or 2\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Myocardial infarction within 6 months prior to enrollment or uncontrolled angina\n* Severe uncontrolled ventricular arrhythmias\n* ECG evidence of acute ischemia or active conduction system abnormalities\n* Female subjects either pregnant or breast-feeding\n* Serious medical or psychiatric illness\n* Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)\n* History of severe hepatic dysfunction\n* Active infections or HIV positivity\n* Uncontrolled insulin-dependent diabetes mellitus\n* Uncompensated major thyroid or adrenal dysfunction\n* Hemodialysis or peritoneal dialysis\n* Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)\n* ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)'}, 'identificationModule': {'nctId': 'NCT01553357', 'briefTitle': 'Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Centro di Riferimento Oncologico della Basilicata'}, 'officialTitle': 'A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia', 'orgStudyIdInfo': {'id': 'CROB0108/1 -- RV-PCL-PI-350'}, 'secondaryIdInfos': [{'id': '2008-003246-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lenalidomide, dexamethasone', 'type': 'DRUG', 'otherNames': ['Revlimid'], 'description': 'Enrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle.\n\nPatients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'Pz', 'country': 'Italy', 'facility': 'IRCCS - CROB Ethic Committee', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}], 'overallOfficials': [{'name': 'Pellegrino Musto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GIMEMA Multiple Myeloma Working Party'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Centro di Riferimento Oncologico della Basilicata', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Onco-Hematology Department Director at IRCCS-CROB Rionero in Vulture, Italy', 'investigatorFullName': 'Pellegrino Musto', 'investigatorAffiliation': 'IRCCS Centro di Riferimento Oncologico della Basilicata'}}}}