Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-20 @ 6:22 PM
Study NCT ID:
NCT01530594
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated 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': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone', 'timeFrame': 'Four years'}]}, 'conditionsModule': {'keywords': ['Untreated', 'Without intent for immediate autologous stem cell transplant'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Patients must have newly diagnosed multiple myeloma\n2. Patients must have received no prior chemotherapy for this disease. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration. Patients must not have received any prior treatment with bortezomib or lenalidomide.\n3. Patients must be ≥ 18 years of age at the time of registration.\n4. Patients must have a Zubrod Performance Status (PS) of 0 - 3\n5. Patients must have adequate marrow function as defined herein:\n6. Platelet count ≥ 80 x 103/mcL,\n7. ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.\n8. Institutions must submit a local cytogenetics report and FISH analysis report\n9. Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.\n10. Patients must have a calculated or measured creatinine clearance \\> 30 cc/min.\n11. Patients must not have uncontrolled, active infection requiring intravenous antibiotics\n12. Patients must not have any psychiatric illness\n13. Patients must not be Hepatitis B, Hepatitis C or HIV positive\n14. Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.\n15. Patients must be able to take aspirin 325 mg daily\n16. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test\n17. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.\n18. Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.'}, 'identificationModule': {'nctId': 'NCT01530594', 'briefTitle': 'Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma', 'orgStudyIdInfo': {'id': '2081-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lenalidomide', 'description': 'Lenalidomide/Low dose Dex (LLD)', 'interventionNames': ['Drug: Lenalidomide/Low dose Dex', 'Drug: Lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'Bortezomib/Lenalidomide', 'description': 'Bortezomib/Lenalidomide/ Low dose Dex (BLLD)', 'interventionNames': ['Drug: Bortezomib/Lenalidomide/ Low dose Dex']}], 'interventions': [{'name': 'Lenalidomide/Low dose Dex', 'type': 'DRUG', 'description': 'Lenalidomide/Low dose Dex (LLD)', 'armGroupLabels': ['Lenalidomide']}, {'name': 'Bortezomib/Lenalidomide/ Low dose Dex', 'type': 'DRUG', 'description': 'Bortezomib/Lenalidomide/ Low dose Dex (BLLD)', 'armGroupLabels': ['Bortezomib/Lenalidomide']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Lenalidomide/Low dose Dex (LLD', 'armGroupLabels': ['Lenalidomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital &Reseach Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}