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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-59105 | Other Identifier | Roswell Park Cancer Institute |
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RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated multiple myeloma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease who continue to show response after completion of 6 courses may receive 2 additional courses for a total of 8 courses.
After completion of study treatment, patients are followed every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug | IV |
| |
| pegylated liposomal doxorubicin hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Complete and Partial) | Every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Every 3 months | |
| Time to Disease Progression | Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first |
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DISEASE CHARACTERISTICS:
Diagnosis of stage I, II, or III multiple myeloma requiring therapy
No prior systemic therapy for multiple myeloma
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Pregnant or lactating
Active, serious infections uncontrolled by antibiotics
Any medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial
History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or bortezomib, boron, or mannitol
Any of the following conditions:
Peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kelvin Lee, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide | Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
IV |
|
| thalidomide | Drug | Oral |
|
| Treated With Study Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Evaluable Patients
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| ID | Title | Description |
|---|---|---|
| BG000 | VDT: VELCADE, Doxil and Low-dose Thalidomide |
| 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 |
| |||||||||||||||||
| Gender | 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 | Overall Response Rate (Complete and Partial) | Evaluable patients | Posted | Number | 95% Confidence Interval | percentage of participants | Every 3 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Complete Response Rate | Evaluable patients. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 3 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | Posted | Median | 95% Confidence Interval | months | Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first |
|
|
|
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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 | VDT: VELCADE, Doxil and Low-dose Thalidomide | 16 | 44 | 44 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bradycardia - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive - Grade 3 | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Hypothyroidism - Grade 2 | Endocrine disorders | Systematic Assessment |
| ||
| Asthenia - Grade 2 | General disorders | Systematic Assessment |
| ||
| Chills - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema peripheral - Grade 3 | General disorders | Systematic Assessment |
| ||
| Pain - Grade 2 | General disorders | Systematic Assessment |
| ||
| Pyrexia - Grade 1 | General disorders | Systematic Assessment |
| ||
| Pyrexia - Grade 2 | General disorders | Systematic Assessment |
| ||
| Pyrexia - Grade 3 | General disorders | Systematic Assessment |
| ||
| Pneumococcal bacteraemia - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Sepsis - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Lipids abnormal - Grade 1 | Investigations | Systematic Assessment |
| ||
| Cachexia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Failure to thrive - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic acidosis - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain - Grade 3 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Polyneuropathy - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Spinal cord compression - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Suicide attempt - Grade 4 | Psychiatric disorders | Systematic Assessment |
| ||
| Renal failure acute - Grade 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Interstitial lung disease - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion - Grade 4 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure - Grade 4 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension - Grade 2 | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 4 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bradycardia - Grade 1 | Cardiac disorders | Systematic Assessment |
| ||
| Cyanosis - Grade 1 | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia - Grade 1 | Cardiac disorders | Systematic Assessment |
| ||
| Deafness - Grade 1 | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Deafness - Grade 2 | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear pain - Grade 1 | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Blepharitis - Grade 2 | Eye disorders | Systematic Assessment |
| ||
| Diplopia - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Dry eye - Grade 2 | Eye disorders | Systematic Assessment |
| ||
| Eye swelling - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Eyelid ptosis - Grade 2 | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Meibomianitis - Grade 2 | Eye disorders | Systematic Assessment |
| ||
| Vision blurred - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Vision blurred - Grade 2 | Eye disorders | Systematic Assessment |
| ||
| Visual disturbance - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Abdominal discomfort - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia - Grade 1 | General disorders | Systematic Assessment |
| ||
| Asthenia - Grade 2 | General disorders | Systematic Assessment |
| ||
| Axillary pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Chest discomfort - Grade 1 | General disorders | Systematic Assessment |
| ||
| Chest pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Chills - Grade 1 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 1 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 2 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 3 | General disorders | Systematic Assessment |
| ||
| Feeling hot - Grade 1 | General disorders | Systematic Assessment |
| ||
| Gait disturbance - Grade 1 | General disorders | Systematic Assessment |
| ||
| Gait disturbance - Grade 2 | General disorders | Systematic Assessment |
| ||
| Influenza like illness - Grade 1 | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema - Grade 2 | General disorders | Systematic Assessment |
| ||
| Oedema peripheral - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema peripheral - Grade 2 | General disorders | Systematic Assessment |
| ||
| Pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Pain - Grade 2 | General disorders | Systematic Assessment |
| ||
| Pyrexia - Grade 1 | General disorders | Systematic Assessment |
| ||
| Tenderness - Grade 1 | General disorders | Systematic Assessment |
| ||
| Xerosis - Grade 1 | General disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 1 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 2 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Drug hypersensitivity - Grade 1 | Immune system disorders | Systematic Assessment |
| ||
| Hypersensitivity - Grade 1 | Immune system disorders | Systematic Assessment |
| ||
| Bacterial infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Breast cellulitis - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Cystitis - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Eye infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Furuncle - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Hordeolum - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Lobar pneumonia - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Localised infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Rash pustular - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Tinea cruris - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Tinea infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Tinea pedis - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Open wound - Grade 1 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatine increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatine increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Heart rate decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Heart rate decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Weight increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Anorexia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anorexia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anorexia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperuricaemia - Grade 4 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Oral intake reduced - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain - Grade 3 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bursitis - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal stiffness - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in jaw - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Amnesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Balance disorder - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Burning sensation - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Cluster headache - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Disturbance in attention - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Headache - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Parosmia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Tremor - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state - Grade 4 | Psychiatric disorders | Systematic Assessment |
| ||
| Illusion - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Nervousness - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Panic attack - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Dysuria - Grade 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Pollakiuria - Grade 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Polyuria - Grade 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal tubular acidosis - Grade 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| Pelvic pain - Grade 1 | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal swelling - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Blister - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Decubitus ulcer - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Drug eruption - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Drug eruption - Grade 3 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome - Grade 3 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pigmentation disorder - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus generalised - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash erythematous - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash erythematous - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash erythematous - Grade 3 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash generalised - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash morbilliform - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic - Grade 3 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin atrophy - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin discolouration - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin disorder - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin disorder - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin exfoliation - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin exfoliation - Grade 3 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin irritation - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis - Grade 3 | Vascular disorders | Systematic Assessment |
| ||
| Hypertension - Grade 2 | Vascular disorders | Systematic Assessment |
| ||
| Hypotension - Grade 1 | Vascular disorders | Systematic Assessment |
| ||
| Hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension - Grade 1 | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D000069286 | Bortezomib |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
|
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