Viewing Study NCT00091260

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 2:13 AM
Ignite Modification Date: 2026-02-21 @ 9:56 PM
Study NCT ID: NCT00091260
Status: COMPLETED
Last Update Posted: 2017-02-20
First Post: 2004-09-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], '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'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vaishali.sanchorawala@bmc.org', 'phone': '6176386521', 'title': 'Vaishali Sanchorawala', 'organization': 'Boston Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\ndexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\nlenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone', 'otherNumAtRisk': 82, 'otherNumAffected': 82, 'seriousNumAtRisk': 82, 'seriousNumAffected': 82}], 'otherEvents': [{'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 53, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cardiac, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 61, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Decreased performance status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fever/infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Derm/skin other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Change in appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 33, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dry membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GI other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hemorrhage - nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Easy bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pulmonary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'increased creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 45, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'increased alkylase phosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'increased alanine aminotransferase test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 39, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'muscle cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'numbness - extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pain - muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pain - extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'mood alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 45, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'tingling - extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'post nasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'elevated blood urea nitrogen blood test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ctcae v3'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'organ rejection', 'notes': 'rejection of previously transplanted heart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cardiac, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Decreased Performance Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fever/infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nail Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'infection', 'notes': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'increased creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'decreased phosphate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'increased INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'muscle cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Removed From Study Treatment Due to Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\ndexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\nlenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who had at least one dose of CC-5013'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Hematologic Response With Single-agent CC-5013', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\ndexamethasone: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\nlenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.\n\nPartial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.\n\nFor patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.\n\nFor patients with an elevated serum free light chain assay, a reduction of 50% or more.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 3 cycles of single-agent CC-5013 and underwent subsequent evaluation.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\ndexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\nlenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\ndexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\nlenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\ndexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.\n\nlenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dialysis y/n', 'classes': [{'categories': [{'title': 'on dialysis', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not on dialysis', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2004-09-07', 'resultsFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2004-09-08', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-28', 'studyFirstPostDateStruct': {'date': '2004-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Removed From Study Treatment Due to Toxicities', 'timeFrame': '1 year'}, {'measure': 'Number of Patients With Hematologic Response With Single-agent CC-5013', 'timeFrame': '3 months', 'description': 'Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.\n\nPartial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.\n\nFor patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.\n\nFor patients with an elevated serum free light chain assay, a reduction of 50% or more.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['primary systemic amyloidosis'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '24668858', 'type': 'DERIVED', 'citation': 'Lichtman EI, Seldin DC, Shelton A, Sanchorawala V. Single agent lenalidomide three times a week induces hematologic responses in AL amyloidosis patients on dialysis. Am J Hematol. 2014 Jul;89(7):706-8. doi: 10.1002/ajh.23722. Epub 2014 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis.\n\nPURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis.\n* Determine the objective hematologic response rate in patients treated with this drug.\n* Determine amyloid organ disease response in patients treated with this drug.\n\nSecondary\n\n* Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone.\n* Determine the toxicity of CC-5013 in combination with dexamethasone in these patients.\n\nOUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study.\n\nPatients are followed annually.\n\nPROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary systemic (AL) amyloidosis\n\n * Tissue amyloid deposits or positive fat aspirate\n* Meets 1 of the following criteria for AL type disease:\n\n * Serum or urine monoclonal protein by immunofixation electrophoresis\n * Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* SWOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* White blood count\\> 3,000/mm\\^3\n* Hemoglobin \\> 8 g/dL\n* Platelet count \\> 100,000/mm\\^3\n* Absolute neutrophil count \\> 1,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 2 times upper limit of normal (ULN)\n* aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Prior thalidomide for AL amyloidosis allowed\n\nChemotherapy\n\n* More than 4 weeks since prior cytotoxic chemotherapy\n\nEndocrine therapy\n\n* Prior steroids for AL amyloidosis allowed\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy\n\nSurgery\n\n* Prior surgery allowed\n\nOther\n\n* Recovered from all prior therapy\n\nExclusion Criteria:\n\n* No secondary or familial amyloidosis\n* No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions\n* No prior CC-5013\n\nRenal\n\n* No dialysis\n\nCardiovascular\n\n* No symptomatic cardiac arrhythmia\n* No oxygen-dependent restrictive cardiomyopathy\n\nOther\n\n* No untreated or uncontrolled infection\n* No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast\n* No other serious medical illness that would preclude study participation\n* No history of hypersensitivity reaction to thalidomide\n* HIV negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception'}, 'identificationModule': {'nctId': 'NCT00091260', 'briefTitle': 'CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis', 'orgStudyIdInfo': {'id': 'CDR0000385687'}, 'secondaryIdInfos': [{'id': 'BUMC-H-23235', 'type': 'OTHER', 'domain': 'Boston University Medical Center IRB'}, {'id': 'CELGENE-RV-AMYL-PI-003', 'type': 'OTHER_GRANT', 'domain': 'Celgene'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'revlimid', 'description': 'lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.', 'interventionNames': ['Drug: dexamethasone', 'Drug: lenalidomide']}], 'interventions': [{'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['dexamethasone acetate'], 'description': 'dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.', 'armGroupLabels': ['revlimid']}, {'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['revlimid; CC-5013'], 'description': '15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone', 'armGroupLabels': ['revlimid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cancer Research Center at Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David C. Seldin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vaishali Sanchorawala', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vaishali Sanchorawala', 'investigatorAffiliation': 'Boston Medical Center'}}}}