ID

40930

Description

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01484275

Link

https://clinicaltrials.gov/show/NCT01484275

Keywords

Versions (1)
  1. 6/7/20 6/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility High-risk Smoldering Multiple Myeloma NCT01484275

English

Eligibility High-risk Smoldering Multiple Myeloma NCT01484275

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of smoldering multiple myeloma (smm) for <4 years
Description

Smoldering myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1531608
diagnosis of high-risk smm (defined as bone marrow plasma cells >=10% and either serum monoclonal protein >=3 g/dl, or abnormal free light chain ratio <0.126 or >8 and serum m-protein <3 g/dl but >=1 g/dl)
Description

High risk Smoldering myeloma | Bone marrow plasma cells Percentage | Serum Monoclonal Protein Measurement | Free Light Chain Ratio Measurement Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C4319571
UMLS CUI [1,2]
C1531608
UMLS CUI [2,1]
C2238293
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C0229671
UMLS CUI [3,2]
C2984963
UMLS CUI [4,1]
C3274398
UMLS CUI [4,2]
C0205161
patients must be within certain limits for protocol-specified laboratory tests
Description

Laboratory Results Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
eastern cooperative oncology group (ecog) performance status score of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
Description

Postmenopausal state | Female Sterilization | Pregnancy Unable

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1299582
women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Egg Donation Absent | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C4053456
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent
Description

Gender | Barrier Contraception Double | Sperm donation Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [3,1]
C0871414
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency; symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia
Description

Multiple Myeloma Symptomatic | Lytic lesion | Severe osteopenia | Pathological fracture | Hypercalcemia | Renal Insufficiency | Hyperviscosity Symptomatic | Bacterial Infections Serious Recurrent | Pneumonia

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0221204
UMLS CUI [3]
C1970459
UMLS CUI [4]
C0016663
UMLS CUI [5]
C0020437
UMLS CUI [6]
C1565489
UMLS CUI [7,1]
C0221104
UMLS CUI [7,2]
C0231220
UMLS CUI [8,1]
C0004623
UMLS CUI [8,2]
C0205404
UMLS CUI [8,3]
C2945760
UMLS CUI [9]
C0032285
primary systemic amyloid light (al) chain amyloidosis (a build-up of amyloid light chain proteins in the blood)
Description

Primary amyloidosis

Data type

boolean

Alias
UMLS CUI [1]
C0268381
prior or concurrent exposure to approved or investigational multiple myeloma treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are only allowed if given in a stable dose and for a nonmalignant condition; concurrent treatment with erythropoietin-stimulating agents (esas) are not allowed.)
Description

Therapy Multiple Myeloma | Investigational Therapy Multiple Myeloma | Diphosphonates Stable allowed | Denosumab Stable allowed | Steroids Stable allowed | Erythropoiesis-stimulating Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C0012544
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C1690432
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C0205360
UMLS CUI [5,3]
C0683607
UMLS CUI [6]
C2917382
prior exposure to agents targeting interleukin 6 (il 6) or the il 6 receptor
Description

Pharmacologic Substance Targeting Interleukin-6 | Pharmacologic Substance Targeting Interleukin 6 Receptor

Data type

boolean

Alias
UMLS CUI [1,1]
C1254351
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0021760
UMLS CUI [2,1]
C1254351
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0063717
other malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or international federation of gynecology and obstetrics stage 1 carcinoma of the cervix
Description

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Cervix carcinoma Treated | Exception Cervix carcinoma TNM clinical staging Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0302592
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0302592
UMLS CUI [5,3]
C3258246
UMLS CUI [5,4]
C1522326
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Similar models

Eligibility High-risk Smoldering Multiple Myeloma NCT01484275

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Smoldering myeloma
Item
diagnosis of smoldering multiple myeloma (smm) for <4 years
boolean
C1531608 (UMLS CUI [1])
High risk Smoldering myeloma | Bone marrow plasma cells Percentage | Serum Monoclonal Protein Measurement | Free Light Chain Ratio Measurement Abnormal
Item
diagnosis of high-risk smm (defined as bone marrow plasma cells >=10% and either serum monoclonal protein >=3 g/dl, or abnormal free light chain ratio <0.126 or >8 and serum m-protein <3 g/dl but >=1 g/dl)
boolean
C4319571 (UMLS CUI [1,1])
C1531608 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0229671 (UMLS CUI [3,1])
C2984963 (UMLS CUI [3,2])
C3274398 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
Laboratory Results Study Protocol
Item
patients must be within certain limits for protocol-specified laboratory tests
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Pregnancy Unable
Item
women not of childbearing potential must be postmenopausal, permanently sterilized, or otherwise incapable of pregnancy
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods | Childbearing Potential Egg Donation Absent | Childbearing Potential Pregnancy test negative
Item
women of childbearing potential must agree to use adequate birth control measures and agree to not donate eggs for the purpose of assisted reproduction during the study and for 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C4053456 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Gender | Barrier Contraception Double | Sperm donation Absent
Item
men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study agent
boolean
C0079399 (UMLS CUI [1])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0871414 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma Symptomatic | Lytic lesion | Severe osteopenia | Pathological fracture | Hypercalcemia | Renal Insufficiency | Hyperviscosity Symptomatic | Bacterial Infections Serious Recurrent | Pneumonia
Item
having symptomatic multiple myeloma, defined by any of the following (if due to myeloma): lytic bone lesions, severe osteopenia (low bone density), pathologic fractures, hypercalcemia (too much calcium in the blood), kidney insufficiency; symptomatic hyperviscosity of the blood, or recurrent serious bacterial infections such as pneumonia
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0221204 (UMLS CUI [2])
C1970459 (UMLS CUI [3])
C0016663 (UMLS CUI [4])
C0020437 (UMLS CUI [5])
C1565489 (UMLS CUI [6])
C0221104 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0004623 (UMLS CUI [8,1])
C0205404 (UMLS CUI [8,2])
C2945760 (UMLS CUI [8,3])
C0032285 (UMLS CUI [9])
Primary amyloidosis
Item
primary systemic amyloid light (al) chain amyloidosis (a build-up of amyloid light chain proteins in the blood)
boolean
C0268381 (UMLS CUI [1])
Therapy Multiple Myeloma | Investigational Therapy Multiple Myeloma | Diphosphonates Stable allowed | Denosumab Stable allowed | Steroids Stable allowed | Erythropoiesis-stimulating Agent
Item
prior or concurrent exposure to approved or investigational multiple myeloma treatments (concurrent treatment with bone-protecting agents (eg, bisphosphonates, denosumab), or steroids (not exceeding 10 mg prednisone per day or equivalent) are only allowed if given in a stable dose and for a nonmalignant condition; concurrent treatment with erythropoietin-stimulating agents (esas) are not allowed.)
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0012544 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C1690432 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0038317 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C2917382 (UMLS CUI [6])
Pharmacologic Substance Targeting Interleukin-6 | Pharmacologic Substance Targeting Interleukin 6 Receptor
Item
prior exposure to agents targeting interleukin 6 (il 6) or the il 6 receptor
boolean
C1254351 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0021760 (UMLS CUI [1,3])
C1254351 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0063717 (UMLS CUI [2,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Cervix carcinoma Treated | Exception Cervix carcinoma TNM clinical staging Treated
Item
other malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or international federation of gynecology and obstetrics stage 1 carcinoma of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0302592 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
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