ID

36418

Beschreibung

Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02206425

Link

https://clinicaltrials.gov/show/NCT02206425

Stichworte

Versionen (1)
  1. 13.05.19 13.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02206425

Englisch

Eligibility Multiple Myeloma NCT02206425

1 Formulare  
Criteria
Beschreibung

Criteria

1. male or female patients 18 years or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must have a diagnosis of mm, based on standard criteria2 as follows:
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
major criteria:
Beschreibung

Criteria Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205164
1. plasmacytomas on tissue biopsy
Beschreibung

Plasmacytoma Biopsy tissue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032131
UMLS CUI [1,2]
C3864006
2. bone marrow plasmacytosis (greater than 30% plasma cells)
Beschreibung

BONE MARROW PLASMACYTOSIS Plasma Cells Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238803
UMLS CUI [1,2]
C0032112
UMLS CUI [1,3]
C0439165
3. monoclonal immunoglobulin spike on serum electrophoresis igg greater than 3.5 g/dl or iga greater than 2.0 g/dl; kappa or lambda light chain excretion greater than 1 g/day on 24 hour urine protein electrophoresis
Beschreibung

Monoclonal immunoglobulin present Serum electrophoresis test Immunoglobulin G measurement | Monoclonal immunoglobulin present Serum electrophoresis test Immunoglobulin A measurement | Kappa light chain measurement 24-hour urine protein electrophoresis | Lambda light chain measurement 24-hour urine protein electrophoresis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0860896
UMLS CUI [1,2]
C0851095
UMLS CUI [1,3]
C0202087
UMLS CUI [2,1]
C0860896
UMLS CUI [2,2]
C0851095
UMLS CUI [2,3]
C0202083
UMLS CUI [3,1]
C1295169
UMLS CUI [3,2]
C2321676
UMLS CUI [4,1]
C1295175
UMLS CUI [4,2]
C2321676
minor criteria:
Beschreibung

Criteria Minor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205165
1. bone marrow plasmacytosis (10% to 30% plasma cells)
Beschreibung

BONE MARROW PLASMACYTOSIS Plasma Cells Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0238803
UMLS CUI [1,2]
C0032112
UMLS CUI [1,3]
C0439165
2. monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
Beschreibung

Monoclonal immunoglobulin Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0443737
UMLS CUI [1,2]
C0150312
3. lytic bone lesions
Beschreibung

Lytic bone lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C0221204
4. normal igm less than 50 mg/dl, iga less than 100 mg/dl, or igg less than 600 mg/dl
Beschreibung

Immunoglobulin M measurement | Immunoglobulin A measurement | Immunoglobulin G measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202084
UMLS CUI [2]
C0202083
UMLS CUI [3]
C0202087
any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
Beschreibung

Criteria Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0026764
any 2 of the major criteria
Beschreibung

Criteria Major Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1265611
major criterion 1 plus minor criterion 2, 3, or 4
Beschreibung

Criteria Major Quantity | Criteria Minor Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0205165
UMLS CUI [2,3]
C1265611
major criterion 3 plus minor criterion 1 or 3
Beschreibung

Criteria Major Quantity | Criteria Minor Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0205165
UMLS CUI [2,3]
C1265611
minor criteria 1, 2, and 3, or 1, 2, and 4 3. currently has progressive mm that has previously progressed or is currently progressing while receiving or within 8 weeks of receiving bortezomib or carfilzomib as part of a combination treatment. mm patients that demonstrate refractory disease, as defined below, are both eligible for enrollment provided they fulfill the other eligibility criteria:
Beschreibung

Criteria Minor Quantity | Multiple Myeloma Progressive | bortezomib | carfilzomib | Combined Modality Therapy | Multiple Myeloma Refractory Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205165
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0205329
UMLS CUI [3]
C1176309
UMLS CUI [4]
C2001856
UMLS CUI [5]
C0009429
UMLS CUI [6,1]
C0026764
UMLS CUI [6,2]
C1514815
patients are refractory to a bortezomib or carfilzomib combination regimen, when they progress while currently receiving a bortezomib or carfilzomib combination treatment, or within 8 weeks of its last dose. prior treatment with four days or less of a total of 400 mg of prednisone (or an equivalent potency of another steroid) for mm will not be considered a regimen 4. patients that were on bortezomib-containing regimens must have been administered at least 4 doses of a minimum of 1.0 mg/m2 in no more than 28-days cycles. subjects must have received at least one cycle meeting this definition and have shown pd to be considered eligible 5. patients that were on carfilzomib-containing regimens must have received at least 6 doses of at least 27 mg/m2 in no more than 28 days per cycle. subjects must have received at least one cycle meeting this definition and have shown pd to be considered eligible 6. progressed from one of the specific bortezomib- or carfilzomib-containing regimens as listed on page 44. although bortezomib- and carfilzomib-containing combination regimens that are otherwise identical except for the pi result in the same ixazomib regimen, they will be enrolled separately so that safety/efficacy can be separately determined, thereby allowing comparisons based on the prior pi that subjects were exposed to as part of the regimen that they failed (carfilzomib vs. bortezomib) 7. patient may have received a carfilzomib- or bortezomib-containing regimen at any time and may have received other non-proteasome inhibitor-containing intervening treatments
Beschreibung

Refractory Bortezomib Combined Modality Therapy | Refractory Carfilzomib Combined Modality Therapy | Disease Progression | Bortezomib Dose Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C0009429
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C2001856
UMLS CUI [2,3]
C0009429
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1176309
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C1265611
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. patient has been diagnosed with:
Beschreibung

Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011900
1. plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (m protein) and skin changes (poems) syndrome.3
Beschreibung

Plasma cell dyscrasia | POEMS Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C1136084
UMLS CUI [2]
C0085404
2. primary amyloidosis
Beschreibung

Primary amyloidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0268381
3. plasma cell leukemia
Beschreibung

Leukemia, Plasma Cell

Datentyp

boolean

Alias
UMLS CUI [1]
C0023484
4. severe hypercalcemia, i.e., serum calcium = 12 mg/dl (3.0 mmol/l) corrected for albumin
Beschreibung

Hypercalcemia Severe | Corrected serum calcium measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0455288
2. non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
Beschreibung

Malignant Neoplasms | Exception Hematologic Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Thyroid carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Prostate carcinoma Gleason Grading System | Exception PSA Level Stable | Exception Malignant Neoplasm Cured Excision | Exception Impact Life Expectancy Unlikely | Exception Transitional cell carcinoma of bladder Localized | Exception Benign neoplasm of adrenal gland | Exception Benign tumor of pancreas

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0376545
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0549473
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0686288
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0600139
UMLS CUI [8,3]
C0332326
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C4086720
UMLS CUI [9,3]
C0205360
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0006826
UMLS CUI [10,3]
C1880198
UMLS CUI [10,4]
C0728940
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C4049986
UMLS CUI [11,3]
C0023671
UMLS CUI [11,4]
C0750558
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0279680
UMLS CUI [12,3]
C0392752
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0154040
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0347284
3. impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, new york heart association (nyha) class ii or greater heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or multigated acquisition scan (muga) evidence of left ventricular ejection fraction (lvef) below institutional normal within 28 days prior to enrollment, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant
Beschreibung

Decreased cardiac function | Heart Disease | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Ventricular arrhythmia Severe Uncontrolled | LVEF by echocardiogram | Left ventricular ejection fraction MUGA scan | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0265122
UMLS CUI [7,1]
C0085612
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0205318
UMLS CUI [8]
C3837263
UMLS CUI [9,1]
C0428772
UMLS CUI [9,2]
C0521317
UMLS CUI [10,1]
C0022116
UMLS CUI [10,2]
C1623258
UMLS CUI [11,1]
C0151236
UMLS CUI [11,2]
C1623258
4. patient has peripheral neuropathy grade 3 or higher or grade 2 with pain on clinical examination during the screening period
Beschreibung

Peripheral Neuropathy CTCAE Grades | Pain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0030193
5. patient has received the following prior therapy:
Beschreibung

Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
1. chemotherapy within 21 days of enrollment (6 weeks for nitrosoureas)
Beschreibung

Prior Chemotherapy | Nitrosoureas

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0028210
2. corticosteroids (>10 mg/day prednisone or equivalent) within 21 days of enrollment
Beschreibung

Adrenal Cortex Hormones | Prednisone U/day | Equivalent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
3. immunotherapy or antibody therapy as well as thalidomide, pomalidomide, lenalidomide, arsenic trioxide, carfilzomib, or bortezomib within 21 days before enrollment
Beschreibung

Immunotherapy | Antibody therapy | Thalidomide | pomalidomide | lenalidomide | arsenic trioxide | carfilzomib | bortezomib

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0281176
UMLS CUI [3]
C0039736
UMLS CUI [4]
C2347624
UMLS CUI [5]
C1144149
UMLS CUI [6]
C0052416
UMLS CUI [7]
C2001856
UMLS CUI [8]
C1176309
5. known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent 6. known gi disease or gi procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Investigational New Drug Excipient | Gastrointestinal Disease Interferes with Absorption Ixazomib | Gastrointestinal procedure Interferes with Absorption Ixazomib | Gastrointestinal Disease Interferes with Tolerance Ixazomib | Gastrointestinal procedure Interferes with Tolerance Ixazomib | Able to swallow Ixazomib Difficult

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0243071
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C3273711
UMLS CUI [5,1]
C1536478
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0237442
UMLS CUI [5,4]
C3273711
UMLS CUI [6,1]
C0017178
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0013220
UMLS CUI [6,4]
C3273711
UMLS CUI [7,1]
C1536478
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0013220
UMLS CUI [7,4]
C3273711
UMLS CUI [8,1]
C2712086
UMLS CUI [8,2]
C3273711
UMLS CUI [8,3]
C0332218
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT02206425

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
1. male or female patients 18 years or older
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma
Item
2. patients must have a diagnosis of mm, based on standard criteria2 as follows:
boolean
C0026764 (UMLS CUI [1])
Criteria Major
Item
major criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Plasmacytoma Biopsy tissue
Item
1. plasmacytomas on tissue biopsy
boolean
C0032131 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
BONE MARROW PLASMACYTOSIS Plasma Cells Percentage
Item
2. bone marrow plasmacytosis (greater than 30% plasma cells)
boolean
C0238803 (UMLS CUI [1,1])
C0032112 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Monoclonal immunoglobulin present Serum electrophoresis test Immunoglobulin G measurement | Monoclonal immunoglobulin present Serum electrophoresis test Immunoglobulin A measurement | Kappa light chain measurement 24-hour urine protein electrophoresis | Lambda light chain measurement 24-hour urine protein electrophoresis
Item
3. monoclonal immunoglobulin spike on serum electrophoresis igg greater than 3.5 g/dl or iga greater than 2.0 g/dl; kappa or lambda light chain excretion greater than 1 g/day on 24 hour urine protein electrophoresis
boolean
C0860896 (UMLS CUI [1,1])
C0851095 (UMLS CUI [1,2])
C0202087 (UMLS CUI [1,3])
C0860896 (UMLS CUI [2,1])
C0851095 (UMLS CUI [2,2])
C0202083 (UMLS CUI [2,3])
C1295169 (UMLS CUI [3,1])
C2321676 (UMLS CUI [3,2])
C1295175 (UMLS CUI [4,1])
C2321676 (UMLS CUI [4,2])
Criteria Minor
Item
minor criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0205165 (UMLS CUI [1,2])
BONE MARROW PLASMACYTOSIS Plasma Cells Percentage
Item
1. bone marrow plasmacytosis (10% to 30% plasma cells)
boolean
C0238803 (UMLS CUI [1,1])
C0032112 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Monoclonal immunoglobulin Present
Item
2. monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
boolean
C0443737 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Lytic bone lesion
Item
3. lytic bone lesions
boolean
C0221204 (UMLS CUI [1])
Immunoglobulin M measurement | Immunoglobulin A measurement | Immunoglobulin G measurement
Item
4. normal igm less than 50 mg/dl, iga less than 100 mg/dl, or igg less than 600 mg/dl
boolean
C0202084 (UMLS CUI [1])
C0202083 (UMLS CUI [2])
C0202087 (UMLS CUI [3])
Criteria Multiple Myeloma
Item
any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
boolean
C0243161 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Criteria Major Quantity
Item
any 2 of the major criteria
boolean
C0243161 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Criteria Major Quantity | Criteria Minor Quantity
Item
major criterion 1 plus minor criterion 2, 3, or 4
boolean
C0243161 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C0205165 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Criteria Major Quantity | Criteria Minor Quantity
Item
major criterion 3 plus minor criterion 1 or 3
boolean
C0243161 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C0205165 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Criteria Minor Quantity | Multiple Myeloma Progressive | bortezomib | carfilzomib | Combined Modality Therapy | Multiple Myeloma Refractory Disease
Item
minor criteria 1, 2, and 3, or 1, 2, and 4 3. currently has progressive mm that has previously progressed or is currently progressing while receiving or within 8 weeks of receiving bortezomib or carfilzomib as part of a combination treatment. mm patients that demonstrate refractory disease, as defined below, are both eligible for enrollment provided they fulfill the other eligibility criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0205165 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0026764 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C1176309 (UMLS CUI [3])
C2001856 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C0026764 (UMLS CUI [6,1])
C1514815 (UMLS CUI [6,2])
Refractory Bortezomib Combined Modality Therapy | Refractory Carfilzomib Combined Modality Therapy | Disease Progression | Bortezomib Dose Quantity
Item
patients are refractory to a bortezomib or carfilzomib combination regimen, when they progress while currently receiving a bortezomib or carfilzomib combination treatment, or within 8 weeks of its last dose. prior treatment with four days or less of a total of 400 mg of prednisone (or an equivalent potency of another steroid) for mm will not be considered a regimen 4. patients that were on bortezomib-containing regimens must have been administered at least 4 doses of a minimum of 1.0 mg/m2 in no more than 28-days cycles. subjects must have received at least one cycle meeting this definition and have shown pd to be considered eligible 5. patients that were on carfilzomib-containing regimens must have received at least 6 doses of at least 27 mg/m2 in no more than 28 days per cycle. subjects must have received at least one cycle meeting this definition and have shown pd to be considered eligible 6. progressed from one of the specific bortezomib- or carfilzomib-containing regimens as listed on page 44. although bortezomib- and carfilzomib-containing combination regimens that are otherwise identical except for the pi result in the same ixazomib regimen, they will be enrolled separately so that safety/efficacy can be separately determined, thereby allowing comparisons based on the prior pi that subjects were exposed to as part of the regimen that they failed (carfilzomib vs. bortezomib) 7. patient may have received a carfilzomib- or bortezomib-containing regimen at any time and may have received other non-proteasome inhibitor-containing intervening treatments
boolean
C0205269 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0009429 (UMLS CUI [1,3])
C0205269 (UMLS CUI [2,1])
C2001856 (UMLS CUI [2,2])
C0009429 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3])
C1176309 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Diagnosis
Item
1. patient has been diagnosed with:
boolean
C0011900 (UMLS CUI [1])
Plasma cell dyscrasia | POEMS Syndrome
Item
1. plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (m protein) and skin changes (poems) syndrome.3
boolean
C1136084 (UMLS CUI [1])
C0085404 (UMLS CUI [2])
Primary amyloidosis
Item
2. primary amyloidosis
boolean
C0268381 (UMLS CUI [1])
Leukemia, Plasma Cell
Item
3. plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
Hypercalcemia Severe | Corrected serum calcium measurement
Item
4. severe hypercalcemia, i.e., serum calcium = 12 mg/dl (3.0 mmol/l) corrected for albumin
boolean
C0020437 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0455288 (UMLS CUI [2])
Malignant Neoplasms | Exception Hematologic Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Thyroid carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Prostate carcinoma Gleason Grading System | Exception PSA Level Stable | Exception Malignant Neoplasm Cured Excision | Exception Impact Life Expectancy Unlikely | Exception Transitional cell carcinoma of bladder Localized | Exception Benign neoplasm of adrenal gland | Exception Benign tumor of pancreas
Item
2. non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0376545 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0549473 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0686288 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0600139 (UMLS CUI [8,2])
C0332326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C4086720 (UMLS CUI [9,2])
C0205360 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0006826 (UMLS CUI [10,2])
C1880198 (UMLS CUI [10,3])
C0728940 (UMLS CUI [10,4])
C1705847 (UMLS CUI [11,1])
C4049986 (UMLS CUI [11,2])
C0023671 (UMLS CUI [11,3])
C0750558 (UMLS CUI [11,4])
C1705847 (UMLS CUI [12,1])
C0279680 (UMLS CUI [12,2])
C0392752 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0154040 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0347284 (UMLS CUI [14,2])
Decreased cardiac function | Heart Disease | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Ventricular arrhythmia Severe Uncontrolled | LVEF by echocardiogram | Left ventricular ejection fraction MUGA scan | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography
Item
3. impaired cardiac function or clinically significant cardiac diseases, including myocardial infarction within 6 months prior to enrollment, new york heart association (nyha) class ii or greater heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, echocardiogram or multigated acquisition scan (muga) evidence of left ventricular ejection fraction (lvef) below institutional normal within 28 days prior to enrollment, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0002962 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0265122 (UMLS CUI [6])
C0085612 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0205318 (UMLS CUI [7,3])
C3837263 (UMLS CUI [8])
C0428772 (UMLS CUI [9,1])
C0521317 (UMLS CUI [9,2])
C0022116 (UMLS CUI [10,1])
C1623258 (UMLS CUI [10,2])
C0151236 (UMLS CUI [11,1])
C1623258 (UMLS CUI [11,2])
Peripheral Neuropathy CTCAE Grades | Pain
Item
4. patient has peripheral neuropathy grade 3 or higher or grade 2 with pain on clinical examination during the screening period
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Prior Therapy
Item
5. patient has received the following prior therapy:
boolean
C1514463 (UMLS CUI [1])
Prior Chemotherapy | Nitrosoureas
Item
1. chemotherapy within 21 days of enrollment (6 weeks for nitrosoureas)
boolean
C1514457 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
Adrenal Cortex Hormones | Prednisone U/day | Equivalent
Item
2. corticosteroids (>10 mg/day prednisone or equivalent) within 21 days of enrollment
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Immunotherapy | Antibody therapy | Thalidomide | pomalidomide | lenalidomide | arsenic trioxide | carfilzomib | bortezomib
Item
3. immunotherapy or antibody therapy as well as thalidomide, pomalidomide, lenalidomide, arsenic trioxide, carfilzomib, or bortezomib within 21 days before enrollment
boolean
C0021083 (UMLS CUI [1])
C0281176 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C2347624 (UMLS CUI [4])
C1144149 (UMLS CUI [5])
C0052416 (UMLS CUI [6])
C2001856 (UMLS CUI [7])
C1176309 (UMLS CUI [8])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Investigational New Drug Excipient | Gastrointestinal Disease Interferes with Absorption Ixazomib | Gastrointestinal procedure Interferes with Absorption Ixazomib | Gastrointestinal Disease Interferes with Tolerance Ixazomib | Gastrointestinal procedure Interferes with Tolerance Ixazomib | Able to swallow Ixazomib Difficult
Item
5. known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent 6. known gi disease or gi procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0017178 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C3273711 (UMLS CUI [4,4])
C1536478 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C3273711 (UMLS CUI [5,4])
C0017178 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0013220 (UMLS CUI [6,3])
C3273711 (UMLS CUI [6,4])
C1536478 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0013220 (UMLS CUI [7,3])
C3273711 (UMLS CUI [7,4])
C2712086 (UMLS CUI [8,1])
C3273711 (UMLS CUI [8,2])
C0332218 (UMLS CUI [8,3])
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