Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-02 @ 12:26 PM
Study NCT ID:
NCT00911859
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2009-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine']}, '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': 'C504234', 'term': 'siltuximab'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Senior Director', 'organization': 'Janssen R&D BE'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after the last dose of study medication', 'description': 'For Safety analyses all randomized participants who received at least 1 dose of study agents were analyzed. Data are presented for 117 participants in the treatment period (Part 1 and Part 2) and 21 participants who entered maintenance period (after achieving partial response or better in the Part 2 treatment period while receiving VPM+siltuximab)', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.', 'otherNumAtRisk': 53, 'otherNumAffected': 51, 'seriousNumAtRisk': 53, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.', 'otherNumAtRisk': 52, 'otherNumAffected': 51, 'seriousNumAtRisk': 52, 'seriousNumAffected': 30}, {'id': 'EG003', 'title': 'Part 2, Maintenance Period: Siltuximab', 'description': 'Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period', 'otherNumAtRisk': 21, 'otherNumAffected': 15, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Mucosal Discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Spinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'H1n1 Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Nipple Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 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'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cerebral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 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15.1'}, {'term': 'Hypoglycaemic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Lacunar Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Metabolic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 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{'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 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12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Leukocytoclastic Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}, {'term': 'Hypovolaemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '26.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to disease progression, approximately 3 years', 'description': 'CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, \\<5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to disease progression, approximately 3 years', 'description': 'CR or PR was assessed using EBMT criteria. 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Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to disease progression, approximately 3 years', 'description': 'sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \\<=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '518', 'groupId': 'OG000', 'lowerLimit': '460', 'upperLimit': '582'}, {'value': '519', 'groupId': 'OG001', 'lowerLimit': '443', 'upperLimit': '673'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)', 'description': 'PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: all randomized participants.'}, {'type': 'SECONDARY', 'title': '1-year Progression-Free Survival (PFS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '72.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '497', 'groupId': 'OG000', 'lowerLimit': '457', 'upperLimit': '637'}, {'value': '583', 'comment': 'Insufficient number of participants with events; therefore, upper limit of 95% CI not reached.', 'groupId': 'OG001', 'lowerLimit': '449', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication', 'description': 'DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Included participants in the randomized population who achieved CR or PR.'}, {'type': 'SECONDARY', 'title': '1-year Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Percentage of participants who are alive at the end of year 1 after randomization', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of participants with events; therefore, median and 95% CI not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events; therefore, median and upper limit of 95% CI not reached.', 'groupId': 'OG001', 'lowerLimit': '783', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)', 'description': "Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'OG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.78', 'spread': '25.250', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '31.088', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 predose) and Cycle 9 (Week 54)', 'description': 'Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: VMP + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'FG001', 'title': 'Part 2: VMP', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'FG002', 'title': 'Part 2: VMP + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Did not receive study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Maintainance Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Participants who received siltuximab only during the 18-month maintenance period', 'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants followed until death or 3.5 years after the last participant was assigned to treatment', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Participants followed until death or 3.5 years after the last participant was assigned to treatment', 'groupId': 'FG001', 'numSubjects': '53'}, {'comment': 'Participants followed until death or 3.5 years after the last participant was assigned to treatment', 'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '27'}]}]}], 'recruitmentDetails': 'The study was conducted at 40 centers in 12 countries: Australia; France; India; Israel; Italy; Poland; Romania; Russian Federation; Singapore; South Korea; Spain; and the United States.', 'preAssignmentDetails': 'In Part 2, 105 participants received treatment (VMP: 53 and VMP+Siltuximab: 52). In the VMP+Siltuximab arm, 21 participants who achieved partial response or better entered the maintenance period and received only Siltuximab for 18 months, or until disease progression, unacceptable toxicity, or withdrawal from treatment, whichever occurred first.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'BG001', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone)', 'description': 'Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'BG002', 'title': 'Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '70.3', 'spread': '7.27', 'groupId': 'BG001'}, {'value': '71.6', 'spread': '4.76', 'groupId': 'BG002'}, {'value': '71.2', 'spread': '6.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'INDIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'SINGAPORE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'dispFirstSubmitDate': '2014-03-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2009-05-29', 'dispFirstSubmitQcDate': '2014-03-03', 'resultsFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2009-05-29', 'dispFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-17', 'studyFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria', 'timeFrame': 'Up to disease progression, approximately 3 years', 'description': 'CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, \\<5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria', 'timeFrame': 'Up to disease progression, approximately 3 years', 'description': 'CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, \\<5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: \\>=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either \\>=90% or to \\<200 mg for at least 2 determinations 6 weeks apart, \\>=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions'}, {'measure': 'Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria', 'timeFrame': 'Up to disease progression, approximately 3 years', 'description': 'sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \\<=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)', 'description': 'PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.'}, {'measure': '1-year Progression-Free Survival (PFS) Rate', 'timeFrame': '1 year', 'description': 'The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication', 'description': 'DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.'}, {'measure': '1-year Survival Rate', 'timeFrame': '1 year', 'description': 'Percentage of participants who are alive at the end of year 1 after randomization'}, {'measure': 'Overall Survival', 'timeFrame': 'From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)', 'description': "Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause."}, {'measure': 'Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)', 'timeFrame': 'Baseline (Day 1 predose) and Cycle 9 (Week 54)', 'description': 'Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'CNTO328', 'Interleukin-6 (IL-6)', 'Monoclonal antibody', 'Anti-IL-6 monoclonal antibody', 'Bortezomib', 'Velcade', 'Melphalan', 'Prednisone'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '24833354', 'type': 'DERIVED', 'citation': 'San-Miguel J, Blade J, Shpilberg O, Grosicki S, Maloisel F, Min CK, Polo Zarzuela M, Robak T, Prasad SV, Tee Goh Y, Laubach J, Spencer A, Mateos MV, Palumbo A, Puchalski T, Reddy M, Uhlar C, Qin X, van de Velde H, Xie H, Orlowski RZ. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014 Jun 26;123(26):4136-42. doi: 10.1182/blood-2013-12-546374. Epub 2014 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).', 'detailedDescription': 'The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening period up to 2 weeks; treatment period; maintenance period (CNTO 328 hereafter referred to as siltuximab) for a maximum of 18 months and follow up period until the study ends. Part 1 is an open-label (all people know the identity of the intervention), single group safety lead-in part to evaluate the safety of siltuximab. Approximately 12 patients will be treated with siltuximab in combination with VMP. If the safety profile of the combination is acceptable, the study will proceed to Part 2. Part 2 is a randomized (the study medication is assigned by chance), open-label, 2-arm (Arm A: siltuximab + VMP; Arm B: VMP alone) study. Approximately 104 patients will be equally randomized, followed by a maintenance period with siltuximab in particiants in Arm A who achieve a partial response (PR) or better. Particiants in both parts of the study will be treated up to a maximum of nine 6-week cycles provided there is no evidence of disease progression, unacceptable toxicity, or withdrawal from treatment. Study medication will be continued for at least 2 additional cycles after confirmation of complete response, and preferably for the full 9 cycles of the treatment period. Participants who will be receiving maintenance treatment after the 12-month effectiveness analysis may continue to receive treatment with siltuximab only after careful consideration by the treating physician and on evidence of clinical benefit and in the absence of unwarranted toxicities. Safety assessments will include evaluation of adverse events, clinical laboratory tests, eastern cooperative oncology group performance status, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation\n* Eastern cooperative oncology group performance status score of less than or equal to 2\n* Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours\n* Adequate laboratory results that will be confirmed by a study physician\n* Agrees to protocol-defined use of effective contraception\n\nExclusion Criteria:\n\n* Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance\n* Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions\n* Received prior or current systemic therapy or stem cell transplantation for multiple myeloma\n* Peripheral neuropathy or neuropathic pain (Grade 2 or higher)\n* Received radiation therapy, plasmapheresis or surgery within 14 days\n* Transplanted solid organ, with the exception of a corneal transplant\n* Serious concurrent illness or history of uncontrolled heart disease"}, 'identificationModule': {'nctId': 'NCT00911859', 'briefTitle': 'A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients', 'nctIdAliases': ['NCT01710241'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CR015901'}, 'secondaryIdInfos': [{'id': 'CNTO328MMY2001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2008-007157-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: VMP+Siltuximab 11 mg/kg', 'description': 'Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP (Velcade+Melphalan+Prednisone). Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally (by mouth).', 'interventionNames': ['Drug: Siltuximab11 mg/kg', 'Drug: Velcade (bortezomib)', 'Drug: Melphalan', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg', 'description': 'Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally', 'interventionNames': ['Drug: Siltuximab 8.3 mg/kg or 11 mg/kg', 'Drug: Velcade (bortezomib)', 'Drug: Melphalan', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2, Arm B: VMP', 'description': 'Velcade 1.3 mg/m2 will be administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 will be taken orally', 'interventionNames': ['Drug: Velcade (bortezomib)', 'Drug: Melphalan', 'Drug: Prednisone']}], 'interventions': [{'name': 'Siltuximab11 mg/kg', 'type': 'DRUG', 'otherNames': ['CNTO 328'], 'description': 'Participants will receive siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks in Part 1.', 'armGroupLabels': ['Part 1: VMP+Siltuximab 11 mg/kg']}, {'name': 'Siltuximab 8.3 mg/kg or 11 mg/kg', 'type': 'DRUG', 'otherNames': ['CNTO 328'], 'description': 'Participants will receive siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks for 9 cycles of treatment in Part 2, Arm A and in maintenance period.', 'armGroupLabels': ['Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg']}, {'name': 'Velcade (bortezomib)', 'type': 'DRUG', 'otherNames': ['bortezomib'], 'description': 'Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert in Part 1.', 'armGroupLabels': ['Part 1: VMP+Siltuximab 11 mg/kg']}, {'name': 'Velcade (bortezomib)', 'type': 'DRUG', 'otherNames': ['bortezomib'], 'description': 'Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection for 9 cycles of the treatment period in Part 2. It will be administered twice weekly for first 4 cycles (on Days 1, 4, 8, 11, 22, 25, 29, and 32, followed by a 10-day rest period) and once weekly for next 5 cycles (on Days 1, 8, 22, and 29, followed by a 13-day rest period)', 'armGroupLabels': ['Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': 'Participants will take melphalan 9 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.', 'armGroupLabels': ['Part 1: VMP+Siltuximab 11 mg/kg']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': 'Participants will receive melphalan according to currently approved package inserts. Melphalan 9 mg/m2 will be administered orally for 9 cycles of treatment period in Part 2, Arm A.', 'armGroupLabels': ['Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Participants will take prednisone 60 mg/m2 will be administered orally on Days 1 to 4, followed by a 38-day rest period in Part 1.', 'armGroupLabels': ['Part 1: VMP+Siltuximab 11 mg/kg']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Participants will take prednisone 60 mg/m2 orally for 9 cycles of treatment period in Part 2, Arm A.', 'armGroupLabels': ['Part 2, Arm A: VMP+Siltuximab 8.3 mg/kg or 11 mg/kg']}, {'name': 'Velcade (bortezomib)', 'type': 'DRUG', 'otherNames': ['bortezomib'], 'description': 'Participants will receive Velcade 1.3 mg/m2 as an intravenous bolus injection according to the current approved package insert.', 'armGroupLabels': ['Part 2, Arm B: VMP']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': 'Participants will take melphalan 9 mg/m2 orally according to currently approved package insert.', 'armGroupLabels': ['Part 2, Arm B: VMP']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Participants will take prednisone 60 mg/m2 orally according to the package insert.', 'armGroupLabels': ['Part 2, Arm B: VMP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Adelaide', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Melbourne', 'country': 'Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Ahmedabad', 'country': 'India', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Calicut', 'country': 'India', 'geoPoint': {'lat': 11.6, 'lon': 92.73333}}, {'city': 'Hyderabad', 'country': 'India', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Jaipur', 'country': 'India', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Mumbai', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Afula', 'country': 'Israel', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'country': 'Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Chorzów', 'country': 'Poland', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'city': 'Gdynia', 'country': 'Poland', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Baia Mare', 'country': 'Romania', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'city': 'Brasov', 'country': 'Romania', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Arkhangelsk', 'country': 'Russia', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'country': 'Spain', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Salamanca', 'country': 'Spain', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}], 'overallOfficials': [{'name': 'Janssen Research & Development L.L.C Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development L.L.C'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}