Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 4:06 PM
Study NCT ID:
NCT00950768
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2009-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014182', 'term': 'Transplantation, Autologous'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-31', 'studyFirstSubmitDate': '2009-07-31', 'studyFirstSubmitQcDate': '2009-07-31', 'lastUpdatePostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.'}]}, 'conditionsModule': {'keywords': ['Myeloma', 'Melphalan', 'Autologous transplantation'], 'conditions': ['Multiple Myeloma', 'Diagnosis']}, 'referencesModule': {'references': [{'pmid': '19965659', 'type': 'DERIVED', 'citation': 'Palumbo A, Bringhen S, Bruno B, Falcone AP, Liberati AM, Grasso M, Ria R, Pisani F, Cangialosi C, Caravita T, Levi A, Meloni G, Nozza A, Pregno P, Gabbas A, Callea V, Rizzo M, Annino L, De Stefano V, Musto P, Baldi I, Cavallo F, Petrucci MT, Massaia M, Boccadoro M. Melphalan 200 mg/m(2) versus melphalan 100 mg/m(2) in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study. Blood. 2010 Mar 11;115(10):1873-9. doi: 10.1182/blood-2009-09-241737. Epub 2009 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'In this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e Salmon stage IIA-IIIB measurable multiple myeloma; age \\< 65 years. Exclusion criteria included: prior treatment for myeloma; abnormal cardiac function, defined as systolic ejection fraction \\<50%; abnormal pulmonary spirometry test; serum bilirubins \\> 2.5 times normal and ALAT and/or ASAT \\> 2 times normal; seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.\n\nInduction therapy, PBSC mobilization, and autografting Initial treatment plan included induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan, 100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5 ug/kg, from days +3 until neutrophil count \\> 1000/ul were achieved.\n\nSupportive care and toxicity grading Following autografting, all patients received standard prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0) were used for grading hematological and non-hematological toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria included:\n\n* diagnosis of untreated Durie \\& Salmon stage IIA-IIIB measurable multiple myeloma;\n* age \\< 65 years.\n\nExclusion criteria included:\n\n* prior treatment for myeloma;\n* abnormal cardiac function, defined as systolic ejection fraction \\<50%;\n* abnormal pulmonary spirometry test;\n* serum bilirubins \\> 2.5 times normal and ALAT and/or ASAT \\> 2 times normal;\n* seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.'}, 'identificationModule': {'nctId': 'NCT00950768', 'briefTitle': 'Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Giovanni Battista'}, 'officialTitle': 'GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study', 'orgStudyIdInfo': {'id': 'GISMM2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mel100', 'interventionNames': ['Procedure: Autologous transplantation']}, {'type': 'EXPERIMENTAL', 'label': 'Mel200', 'interventionNames': ['Procedure: Autologous transplantation']}], 'interventions': [{'name': 'Autologous transplantation', 'type': 'PROCEDURE', 'description': 'Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2', 'armGroupLabels': ['Mel100', 'Mel200']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mario Boccadoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Hematology - University of Torino - A.O.U. San Giovanni Battista'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Giovanni Battista', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mario Boccadoro', 'oldOrganization': 'Division of Hematology - University of Torino - A.O.U. San Giovanni Battista'}}}}