ID

15974

Beschrijving

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02316106

Link

https://clinicaltrials.gov/show/NCT02316106

Trefwoorden

Versies (1)
  1. 22-06-16 22-06-16 -
Geüploaded op

22 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Smoldering Multiple Myeloma (SMM) NCT02316106

Engels

Eligibility Smoldering Multiple Myeloma (SMM) NCT02316106

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of smoldering multiple myeloma (smm) for less than 5 years
Beschrijving

Smoldering multiple myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C1531608
have a confirmed diagnosis of intermediate or high-risk smm, and an eastern cooperative oncology group (ecog) performance status score of 0 or 1.
Beschrijving

Smoldering multiple myeloma Intermediate | Smoldering multiple myeloma High risk | ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1,1]
C1531608
UMLS CUI [1,2]
C0205103
UMLS CUI [2,1]
C1531608
UMLS CUI [2,2]
C0332167
UMLS CUI [3]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active multiple myeloma,requiring treatment as defined by the study protocol
Beschrijving

Multiple Myeloma Requirement Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
primary systemic al (immunoglobulin light chain) amyloidosis
Beschrijving

Primary amyloidosis of light chain type Systemic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342606
UMLS CUI [1,2]
C0205373
prior or concurrent exposure to any of the following: approved or investigational treatments for smm or/and multiple myeloma, daratumumab or other anti cd-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before cycle 1, day 1
Beschrijving

Exposure to Following | Therapeutic procedure Smoldering multiple myeloma | Therapeutic procedure Multiple Myeloma | daratumumab | Steroid therapy | Prednisone | Bisphosphonate drugs affecting bone structure and mineralization | Diphosphonates | denosumab | Investigational New Drugs | INVESTIGATIONAL VACCINES | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0332282
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1531608
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0026764
UMLS CUI [4]
C2346801
UMLS CUI [5]
C0149783
UMLS CUI [6]
C0032952
UMLS CUI [7]
C3541401
UMLS CUI [8]
C0012544
UMLS CUI [9]
C1690432
UMLS CUI [10]
C0013230
UMLS CUI [11]
C1875384
UMLS CUI [12]
C2346570
history of malignancy (other than smm) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or international federation of gynecology and obstetrics (figo) stage 1 carcinoma of the cervix
Beschrijving

Malignant Neoplasms Other | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Noninfiltrating Intraductal Carcinoma | Cervix carcinoma stage I

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0851140
UMLS CUI [5]
C0007124
UMLS CUI [6]
C0278575
known chronic obstructive pulmonary disease (copd) or moderate or severe persistent asthma within the past 2 years
Beschrijving

Chronic Obstructive Airway Disease | Moderate persistent asthma | Severe persistent asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C1960047
UMLS CUI [3]
C1960048
any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) 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
Beschrijving

Comorbidity Interferes with Study Protocol | Comorbidity Interferes with research results | Comorbidity At risk Study Subject Participation Status | Autoimmune Diseases | Systemic disease | Myelodysplasia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C2348568
UMLS CUI [4]
C0004364
UMLS CUI [5]
C0442893
UMLS CUI [6]
C0026985
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Similar models

Eligibility Smoldering Multiple Myeloma (SMM) NCT02316106

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Smoldering multiple myeloma
Item
diagnosis of smoldering multiple myeloma (smm) for less than 5 years
boolean
C1531608 (UMLS CUI [1])
Smoldering multiple myeloma Intermediate | Smoldering multiple myeloma High risk | ECOG performance status
Item
have a confirmed diagnosis of intermediate or high-risk smm, and an eastern cooperative oncology group (ecog) performance status score of 0 or 1.
boolean
C1531608 (UMLS CUI [1,1])
C0205103 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C1520224 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma Requirement Therapeutic procedure
Item
active multiple myeloma,requiring treatment as defined by the study protocol
boolean
C0026764 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Primary amyloidosis of light chain type Systemic
Item
primary systemic al (immunoglobulin light chain) amyloidosis
boolean
C0342606 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Exposure to Following | Therapeutic procedure Smoldering multiple myeloma | Therapeutic procedure Multiple Myeloma | daratumumab | Steroid therapy | Prednisone | Bisphosphonate drugs affecting bone structure and mineralization | Diphosphonates | denosumab | Investigational New Drugs | INVESTIGATIONAL VACCINES | Investigational Medical Device
Item
prior or concurrent exposure to any of the following: approved or investigational treatments for smm or/and multiple myeloma, daratumumab or other anti cd-38 therapies, treatment with corticosteroids with a dose greater than (>) 10 milligram (mg) prednisone per day or equivalent and bone-protecting agents (eg, bisphosphonates, denosumab) or are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before cycle 1, day 1
boolean
C0332157 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1531608 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C2346801 (UMLS CUI [4])
C0149783 (UMLS CUI [5])
C0032952 (UMLS CUI [6])
C3541401 (UMLS CUI [7])
C0012544 (UMLS CUI [8])
C1690432 (UMLS CUI [9])
C0013230 (UMLS CUI [10])
C1875384 (UMLS CUI [11])
C2346570 (UMLS CUI [12])
Malignant Neoplasms Other | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Noninfiltrating Intraductal Carcinoma | Cervix carcinoma stage I
Item
history of malignancy (other than smm) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or international federation of gynecology and obstetrics (figo) stage 1 carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0007124 (UMLS CUI [5])
C0278575 (UMLS CUI [6])
Chronic Obstructive Airway Disease | Moderate persistent asthma | Severe persistent asthma
Item
known chronic obstructive pulmonary disease (copd) or moderate or severe persistent asthma within the past 2 years
boolean
C0024117 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
C1960048 (UMLS CUI [3])
Comorbidity Interferes with Study Protocol | Comorbidity Interferes with research results | Comorbidity At risk Study Subject Participation Status | Autoimmune Diseases | Systemic disease | Myelodysplasia
Item
any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) 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
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004364 (UMLS CUI [4])
C0442893 (UMLS CUI [5])
C0026985 (UMLS CUI [6])
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