Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT01559935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2012-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C524865', 'term': 'carfilzomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'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': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'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': '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': 'run9001@med.cornell.edu', 'phone': '6469626500', 'title': 'Ruben Niesvizky, MD', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Collection of adverse events is ongoing as 28 participants are still on trial.\n\nFor the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased.\n\nGrading was done using the CTCAE 4.0.', 'eventGroups': [{'id': 'EG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 72, 'seriousNumAtRisk': 72, 'deathsNumAffected': 1, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'anemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombocytopenia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 64}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leukopenia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lymphopenia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 69}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anorexia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarhhea', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulance', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypocalcemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 56}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyponatremia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoglycemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 63}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypophosphatemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperkalemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypokalemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypomagnesemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypermagnesemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoalbuminemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 39}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperbilirubinemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperuricemia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperhidrosis', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated ALT', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated AST', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated alkaline phosphatase', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased creatinine', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chills', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peripheral neuropathy', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tremor', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety/stress', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'depression', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness / lightheaded', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'paresthesias', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'forgetful', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dysgeusia', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'irritability', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'agitation', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'concentration impairment', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'edema', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle spasms/cramps', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle weakness', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain in legs', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hip pain', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'knee pain', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lower extremity pain', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'high BNP', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'low eGFR', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 37}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'genitourinary frequency', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cough', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sinus congestion', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sore throat', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTI', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Infection', 'notes': 'Car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leukopenia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lymphopenia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anorexia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarhhea', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulance', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypocalcemia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoglycemia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypokalemia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypomagnesemia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated ALT', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALK increase', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased creatinine', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'malaise', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peripheral neuropathy', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tremor', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness / lightheaded', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'parethesias', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dysgeusia', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'irritability', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'edema', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cushingoid appearance', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle spasms/cramps', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hip pain', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bone pain', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritus', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'low eGFR', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspnea', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lung infection', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cough', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sinus congestion', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombocytopenia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neutropenia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'leukopenia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarhhea', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulance', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypocalcemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypercalcemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoglycemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypophosphatemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypokalemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypomagnesemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoalbuminemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperbilirubinemia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyponatremia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypernatremia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated ALT', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated AST', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased creatinine', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gait disturbance', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hair loss', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peripheral neuropathy', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety/stress', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'depression', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness / lightheaded', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'edema', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle spasms/cramps', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shoulder pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rib pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain (muscular)', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain in legs', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hip pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arthralgias', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neck pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain in foot', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lower extremity pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'upper extremity pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'knee pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin darknening', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritus', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry skin', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blurry vision', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bradycardia', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'genitourinary frequency', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lung infection', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cough', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sore throat', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sinus congestion', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'allergic rhinitis', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin Infection', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ear infection', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fall', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'dyspnea', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abnominal infection', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lung infection', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTI', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'femur fracture', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'spinal fracture', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'atrial fibrilation', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'massive heart attack', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'syncope', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fall', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'surgical procedure', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased creatinine', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dehydration', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'confusion', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary embolism', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thyroid cancer', 'notes': 'car phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'non-cardiac chest pain', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain (small intestinal obstruction)', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute coronary syndrome', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lung infection', 'notes': 'BiRD phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thromboembolic event', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'non-cardiac chest pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lung infection', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute kidney infection', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'enterocolitis infection', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac chest pain', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'spinal cord compression', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'creatinine increase', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'secondary malignancy', 'notes': 'Maintenance phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response to Car-BiRD Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'classes': [{'title': 'sCR/CR', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'VGPR', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Not Evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to best response, up to 116 weeks.', 'description': 'The best response for all patients who had at least one dose of drug was measured.\n\nResponse categories:\n\nStringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).\n\nThe response is evaluated based on the IMWG criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '401.5', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '1222'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.', 'description': 'an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.'}, {'type': 'SECONDARY', 'title': 'MRD Negativity Following CarBiRD Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'classes': [{'categories': [{'title': 'MRD positive', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'MRD negative', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study up to Revlimid Maintenance Cycle 4.', 'description': 'Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.\n\nMRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.\n\nMRD positivity is defined as the presence of residual plasma cells (\\<5%) on bone marrow biopsy.\n\nThe IMWG criteria were used to determine CR and sCR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '28 participants achieved CR or sCR.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '40.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of study drug until first incidence of progression, up to 1222 days.', 'description': 'Progression was defined using the IMWG criteria.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '21 participants had an incidence of progression.'}, {'type': 'SECONDARY', 'title': 'Stem Cells Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '12854635', 'spread': '5388946.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.', 'description': 'At the end of the Car Phase, all participants underwent stem cell collection.', 'unitOfMeasure': 'Number of stem cells collected per Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'periods': [{'title': 'Car Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Insurance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'BiRD Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Maintenance Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Remains on study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Two subjects were ineligible and therefore never started treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]\n\nCar Phase:\n\ncarfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.\n\nBiRD Phase:\n\nClarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nLenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nDexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.\n\nMaintenance Phase:\n\nLenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Car Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '85'}]}]}, {'title': 'BiRD Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '85'}]}]}, {'title': 'Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': '72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Car Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'BiRD Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Car Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'BiRD Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Car Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'BiRD Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.'}], 'populationDescription': '72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2017-02-01', 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to Car-BiRD Treatment.', 'timeFrame': 'From baseline to best response, up to 116 weeks.', 'description': 'The best response for all patients who had at least one dose of drug was measured.\n\nResponse categories:\n\nStringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).\n\nThe response is evaluated based on the IMWG criteria.'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': 'From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.', 'description': 'an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.'}, {'measure': 'MRD Negativity Following CarBiRD Regimen', 'timeFrame': 'From start of study up to Revlimid Maintenance Cycle 4.', 'description': 'Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.\n\nMRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.\n\nMRD positivity is defined as the presence of residual plasma cells (\\<5%) on bone marrow biopsy.\n\nThe IMWG criteria were used to determine CR and sCR.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'From start of study drug until first incidence of progression, up to 1222 days.', 'description': 'Progression was defined using the IMWG criteria.'}, {'measure': 'Stem Cells Collection', 'timeFrame': 'At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.', 'description': 'At the end of the Car Phase, all participants underwent stem cell collection.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of an investigational new drug called carfilzomib, in combination with dexamethasone in subjects with newly diagnosed multiple myeloma followed by treatment with a combination of drugs clarithromycin (Biaxin®), lenalidomide (Revlimid®) and dexamethasone (Decadron®) \\[BiRD\\] then lenalidomide alone.', 'detailedDescription': "While new anti-myeloma therapies such as bortezomib and immunomodulatory drugs have been developed, multiple myeloma remains an incurable malignancy. Given that obtaining a complete remission (CR) with therapy will allow patients with newly diagnosed multiple myeloma to enjoy a higher quality of life and longer duration of freedom from disease symptoms, finding an optimally effective and well-tolerated regimen is imperative.\n\nThe robust overall response rate of 91% with the BiRD regimen for patients with newly diagnosed multiple myeloma is encouraging and we believe that by adding carfilzomib the overall response rate and CR rate can be improved. As carfilzomib has proven efficacy in myeloma and in patient's who have relapsed on bortezomib, we anticipate that it will synergize with the previous BiRD regimen to induce greater reduction of tumor burden overall.\n\nThe primary endpoints include best response rate, toxicities, progression free survival, event free survival, and overall survival. In those patients who are eligible for autologous stem cell transplantation, we will also study the effect of carfilzomib on CD 34+ stem cell yield following mobilization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must voluntarily sign and understand written informed consent.\n* Subject is ≥ 18 years at the time of signing the consent form.\n* Subject has histologically confirmed multiple myeloma that has never before been treated.\n* Subject had no anti-myeloma therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse). Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression.\n* Subject has measurable disease as defined by \\> 0.5 g/dL serum monoclonal protein, \\> 10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, \\> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI.\n* Subject has a Karnofsky performance status ≥ 60% (\\> 50% if due to bony involvement of myeloma (see Appendix VI).\n* Subject is able to take prophylactic anticoagulation as detailed in section 9.1 (patients intolerant to aspirin may use warfarin or low molecular weight heparin).\n* Subject is registered into the mandatory RevAssist® program, and is willing and able to comply with the requirements of RevAssist® program.\n* If subject is a female of childbearing potential (FCBP),† she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.\n* Subjects must meet the following laboratory parameters:\n\n * Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L)\n * Hemoglobin ≥ 7 g/dL\n * Platelet count ≥ 30,000/mm3 (75 x 109/L)\n * Serum SGOT/AST \\< 3.0 x upper limits of normal (ULN)\n * Serum SGPT/ALT \\< 3.0 x upper limits of normal (ULN)\n * Serum creatinine \\< 2.5 mg/dL (221 µmol/L)\n * Serum total bilirubin \\< 2.0 mg/dL (34 µmol/L)\n\nExclusion Criteria:\n\n* Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning).\n* Subject has a prior history of other malignancies unless disease free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score \\< 7 with stable prostate specific antigen (PSA) levels.\n* Subject has had myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, Ejection Fraction \\< 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n* Female subject who is pregnant or lactating.\n* Subject has known HIV infection\n* Subject has known active hepatitis B or hepatitis C infection.\n* Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.\n* Subject has known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, thalidomide, allopurinol, or carfilzomib.\n* Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment.\n* Subject has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent."}, 'identificationModule': {'nctId': 'NCT01559935', 'acronym': 'CarBiRD', 'briefTitle': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Phase II Study of Sequential Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Newly Diagnosed Multiple Myeloma', 'orgStudyIdInfo': {'id': '1108011903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Car-BiRD Therapy', 'description': 'Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \\[Car-BiRD\\]', 'interventionNames': ['Drug: carfilzomib', 'Drug: Dexamethasone', 'Drug: Clarithromycin', 'Drug: Lenalidomide']}], 'interventions': [{'name': 'carfilzomib', 'type': 'DRUG', 'description': '45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles.', 'armGroupLabels': ['Car-BiRD Therapy']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['DECADRON®'], 'description': '20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.', 'armGroupLabels': ['Car-BiRD Therapy']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'otherNames': ['Biaxin'], 'description': '500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.', 'armGroupLabels': ['Car-BiRD Therapy']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid'], 'description': '25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.', 'armGroupLabels': ['Car-BiRD Therapy']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.', 'armGroupLabels': ['Car-BiRD Therapy']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid'], 'description': '10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.', 'armGroupLabels': ['Car-BiRD Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ruben Niesvizky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Onyx Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}