{"description":"Arms are not separated by individual cohorts within Phase 1 as information was lost when it was transferred from legacy system. When legacy patient data was transferred, it was decided that only mortality and serious adverse event data should be retained and transferred. Other adverse event (AE) data was not electronically transferred. Paper records were lost in a flood, so participants AE data could not be recovered. The study was terminated and participants not enrolled in Phase 2.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":13,"description":"Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d\n\nMelphalan: IV over 30 min, Day 1 q28d\n\nVelcade®: IV bolus, Day 1, 4, 8, 11 q28d\n\nDose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2\n\nDose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2\n\nDose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2\n\nDose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2","id":"EG000","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":6,"seriousNumAtRisk":13,"title":"Phase 1 Doxil® + Melphalan + Velcade (DMV)"}],"frequencyThreshold":"5","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hyperbilirubinemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Neurological disorder NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Bone Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Lung Infection"}],"timeFrame":"Up to 5 years"}