Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 26866138MMY2031 | Other Identifier | Janssen-Cilag G.m.b.H, Germany | |
| 2005-003902-27 | EudraCT Number |
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The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.
This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide + Bortezomib + Dexamethasone | Experimental | Part 1 will be the dose titration part for cyclophosphamide. Participants will receive cyclophosphamide, bortezomib, and dexamethasone for 3 cycles. In Part 2, participants will receive cyclophosphamide (dose determined in Part 1) with pre-defined dose of bortezomib and dexamethasone for 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set) | CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. | Up to Day 63 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set) | CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag G.m.b.H, Germany Clinical Trial | Janssen-Cilag G.m.b.H | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berg | Germany | |||||
Out of 401 participants, 399 participants were treated in both the Parts. Out of 399 participants, 395 participants were evaluated as 4 participants who had received cyclophophamide dose of greater than 1350 mg/m^2 per cycle in Part 1 were excluded.
401 participants were enrolled at 41 study sites in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclophosphamide + Bortezomib + Dexamethasone | Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Bortezomib | Drug | Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2). |
|
|
| Dexamethasone | Drug | Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2). |
|
| Up to Day 63 |
| Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set) | Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible | Up to Day 63 |
| Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set) | Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible. | Up to Day 63 |
| Berlin |
| Germany |
| Bremen | Germany |
| Dresden | Germany |
| Erlangen | Germany |
| Frankfurt am Main | Germany |
| Freiburg im Breisgau | Germany |
| Göttingen | Germany |
| Greifswald | Germany |
| Halle | Germany |
| Hamburg | Germany |
| Hamm | Germany |
| Hanover | Germany |
| Homburg | Germany |
| Jena | Germany |
| Karlsruhe | Germany |
| Kiel | Germany |
| Lübeck | Germany |
| Magdeburg | Germany |
| Mainz | Germany |
| Mutlangen | Germany |
| München | Germany |
| Münster | Germany |
| Nuremberg | Germany |
| Oldenburg | Germany |
| Potsdam | Germany |
| Regensburg | Germany |
| Rehling | Germany |
| Rostock | Germany |
| Stuttgart | Germany |
| Tübingen | Germany |
| Ulm | Germany |
| Villingen-Schwenningen | Germany |
| Würzburg | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cyclophosphamide + Bortezomib + Dexamethasone | Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Age, Customized | Number | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set) | CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. | Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease). | Posted | Number | Participants | Up to Day 63 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set) | CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. | Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations. | Posted | Number | Participants | Up to Day 63 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set) | Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible | Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker). | Posted | Number | Percentage of participants | Up to Day 63 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set) | Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible. | Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. "n" signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker). | Posted | Number | Percentage of participants | Up to Day 63 |
|
|
From date of inform consent signed to 30 days after the last bortezomib dosing or, if earlier, until start of an alternative myeloma therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclophosphamide + Bortezomib + Dexamethasone | Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles | 103 | 395 | 392 | 395 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Blood immunoglobulin G increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA version 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Epiglottic oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Presbyacusis | Ear and labyrinth disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Areas Director | Jan-Cil Germany | +49 2137 955-492 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Between 50 and 60 years |
|
| >65 years |
|
|
|
|
|