ID

36414

Description

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01998971

Link

https://clinicaltrials.gov/show/NCT01998971

Keywords

Versions (1)
  1. 5/13/19 5/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01998971

English

Eligibility Multiple Myeloma NCT01998971

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease
Description

Multiple Myeloma Symptomatic | Measurable Disease secretory

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1327616
eastern cooperative oncology group performance status score of 0, 1, or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase
Description

Laboratory Results pre treatment | Study Protocol Parameters Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2709094
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0449381
UMLS CUI [2,3]
C1550543
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously received daratumumab or other anti-cd38 therapies
Description

daratumumab | Therapeutic procedure Against CD38 Antigen

Data type

boolean

Alias
UMLS CUI [1]
C2346801
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0075742
diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, waldenström's disease, or other conditions in which igm m-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Description

Primary amyloidosis | Monoclonal Gammopathy | Smoldering myeloma | Waldenstrom Macroglobulinemia | Condition Immunoglobulin M Present | Absence Plasma cell infiltration Clonal | Absence Lytic bone lesion

Data type

boolean

Alias
UMLS CUI [1]
C0268381
UMLS CUI [2]
C1136085
UMLS CUI [3]
C1531608
UMLS CUI [4]
C0024419
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0020861
UMLS CUI [5,3]
C0150312
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0391861
UMLS CUI [6,3]
C1522642
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0221204
peripheral neuropathy or neuropathic pain grade 2 or higher
Description

Peripheral Neuropathy CTCAE grades | Neuropathic pain CTCAE grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C3714625
UMLS CUI [2,2]
C1516728
prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
Description

Invasive cancer | Exception Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026764
exhibiting clinical signs of meningeal involvement of multiple myeloma
Description

Sign or Symptom Meninges Involvement with Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0025285
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0026764
known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years
Description

Chronic Obstructive Airway Disease | Persistent asthma | Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C3266628
UMLS CUI [3]
C0004096
seropositive for human immunodeficiency virus, hepatitis b, or hepatitis c
Description

HIV Seropositivity | Hepatitis B Seropositive | Hepatitis C Seropositive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0521143
any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Description

Medical condition Interferes with Clinical Trial | Mental condition Interferes with Clinical Trial | Medical condition Interferes with Research results | Mental condition Interferes with Research results | Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1444641
clinically significant cardiac disease
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
plasma cell leukemia or poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome
Description

Leukemia, Plasma Cell | POEMS Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0023484
UMLS CUI [2]
C0085404
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Similar models

Eligibility Multiple Myeloma NCT01998971

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic | Measurable Disease secretory
Item
confirmed diagnosis of symptomatic multiple myeloma and measurable secretory disease
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1327616 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group performance status score of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results pre treatment | Study Protocol Parameters Fulfill
Item
pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase
boolean
C1254595 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
daratumumab | Therapeutic procedure Against CD38 Antigen
Item
previously received daratumumab or other anti-cd38 therapies
boolean
C2346801 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0075742 (UMLS CUI [2,3])
Primary amyloidosis | Monoclonal Gammopathy | Smoldering myeloma | Waldenstrom Macroglobulinemia | Condition Immunoglobulin M Present | Absence Plasma cell infiltration Clonal | Absence Lytic bone lesion
Item
diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, waldenström's disease, or other conditions in which igm m-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
boolean
C0268381 (UMLS CUI [1])
C1136085 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
C0024419 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0020861 (UMLS CUI [5,2])
C0150312 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C0391861 (UMLS CUI [6,2])
C1522642 (UMLS CUI [6,3])
C0332197 (UMLS CUI [7,1])
C0221204 (UMLS CUI [7,2])
Peripheral Neuropathy CTCAE grades | Neuropathic pain CTCAE grades
Item
peripheral neuropathy or neuropathic pain grade 2 or higher
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Invasive cancer | Exception Multiple Myeloma
Item
prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
Sign or Symptom Meninges Involvement with Multiple Myeloma
Item
exhibiting clinical signs of meningeal involvement of multiple myeloma
boolean
C3540840 (UMLS CUI [1,1])
C0025285 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0026764 (UMLS CUI [1,4])
Chronic Obstructive Airway Disease | Persistent asthma | Asthma
Item
known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 2 years
boolean
C0024117 (UMLS CUI [1])
C3266628 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B Seropositive | Hepatitis C Seropositive
Item
seropositive for human immunodeficiency virus, hepatitis b, or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
Medical condition Interferes with Clinical Trial | Mental condition Interferes with Clinical Trial | Medical condition Interferes with Research results | Mental condition Interferes with Research results | Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk
Item
any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Leukemia, Plasma Cell | POEMS Syndrome
Item
plasma cell leukemia or poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome
boolean
C0023484 (UMLS CUI [1])
C0085404 (UMLS CUI [2])
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