Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-27 @ 1:53 PM
Study NCT ID:
NCT00006232
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'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'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of response rates'}], 'secondaryOutcomes': [{'measure': 'Time to achieve a maximal response'}, {'measure': 'Duration of response'}]}, 'conditionsModule': {'keywords': ['stage II multiple myeloma', 'stage III multiple myeloma'], 'conditions': ['Multiple Myeloma and Plasma Cell Neoplasm']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.\n\nPURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone.\n* Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.\n* Compare the quality of life of patients treated with these 2 regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only.\n* Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I.\n\nPatients without a maximal response after completion of course 4 may receive up to 2 additional courses.\n\nQuality of life is assessed at baseline and then prior to each study course.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of stage II or III multiple myeloma\n\n * No prior therapy except local radiotherapy to bone lesions\n* No indolent multiple myeloma\n* No monoclonal gammopathy of unknown significance\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 75 and under\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin no greater than 2.34 mg/dL\n\nRenal:\n\n* No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)\n* No requirement for dialysis\n\nOther:\n\n* No other medical condition that would preclude intensive treatment\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other prior malignancy\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* See Disease Characteristics\n\nRadiotherapy\n\n* Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture\n\nSurgery\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00006232', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'WSLG-H31'}, 'secondaryIdInfos': [{'id': 'CDR0000068156', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20032'}, {'id': 'ISRCTN65684689'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dexamethasone', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'idarubicin', 'type': 'DRUG'}, {'name': 'vincristine sulfate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B9 5SS', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool and Broadgreen Hospitals NHS Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Centre for Cancer Research and Cell Biology at Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'G83 0UA', 'city': 'Alexandria', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Vale Of Leven D G Hospital', 'geoPoint': {'lat': 55.99379, 'lon': -4.5864}}, {'zip': 'DG1 4AP', 'city': 'Dumfries', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Dumfries Royal Infirmary', 'geoPoint': {'lat': 55.06959, 'lon': -3.61139}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital and Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G4 0SF', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Infirmary - Castle', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Paisley', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 55.83173, 'lon': -4.43254}}], 'overallOfficials': [{'name': 'Gordon Cook, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Leeds Cancer Centre at St. James's University Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West of Scotland Lymphoma Group', 'class': 'OTHER'}}}}