ID

36415

Description

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02076009

Link

https://clinicaltrials.gov/show/NCT02076009

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 NCT02076009

English

Eligibility Multiple Myeloma NCT02076009

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have documented multiple myeloma and measurable disease
Description

Multiple Myeloma | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1513041
must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
Description

Prior Therapy Quantity Multiple Myeloma | Partial response Prior Therapy | Complete response Prior Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C1514463
must have documented evidence of progressive disease as defined by the international myeloma working group criteria on or after their last regimen
Description

Progressive Disease | Status post Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0087111
must have an eastern cooperative oncology group performance status score of 0, 1, or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has received any of the following therapies: daratumumab or other anti-cd38 therapies
Description

daratumumab | Therapy Against CD38

Data type

boolean

Alias
UMLS CUI [1]
C2346801
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0075742
has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
Description

Therapy Myeloma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
Description

Lenalidomide Refractory | Intolerance to Lenalidomide | Lenalidomide Discontinued Due to Adverse event | Adverse event Relationship Lenalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C1144149
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1144149
UMLS CUI [3,1]
C1144149
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0877248
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C1144149
has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
Description

Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation | Stem cell transplant Planned | Status pre- Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C2242529
UMLS CUI [3,1]
C1504389
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C0242656
history of malignancy (other than multiple myeloma) within 5 years before the date of randomization
Description

Malignant Neoplasms | Exception Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026764
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Similar models

Eligibility Multiple Myeloma NCT02076009

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Measurable Disease
Item
must have documented multiple myeloma and measurable disease
boolean
C0026764 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Prior Therapy Quantity Multiple Myeloma | Partial response Prior Therapy | Complete response Prior Therapy
Item
must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C1521726 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
Progressive Disease | Status post Therapy
Item
must have documented evidence of progressive disease as defined by the international myeloma working group criteria on or after their last regimen
boolean
C1335499 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
ECOG performance status
Item
must have an eastern cooperative oncology group performance status score of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
daratumumab | Therapy Against CD38
Item
has received any of the following therapies: 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])
Therapy Myeloma
Item
has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Lenalidomide Refractory | Intolerance to Lenalidomide | Lenalidomide Discontinued Due to Adverse event | Adverse event Relationship Lenalidomide
Item
disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
boolean
C1144149 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
C1144149 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0877248 (UMLS CUI [3,4])
C0877248 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C1144149 (UMLS CUI [4,3])
Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation | Stem cell transplant Planned | Status pre- Disease Progression
Item
has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
boolean
C1831743 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
C1504389 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0332152 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Multiple Myeloma
Item
history of malignancy (other than multiple myeloma) within 5 years before the date of randomization
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
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