ID

36415

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02076009

Keywords

versioni (1)
  1. 13/05/19 13/05/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

13 maggio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Multiple Myeloma NCT02076009

Inglese

Eligibility Multiple Myeloma NCT02076009

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Multiple Myeloma | Measurable Disease

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Progressive Disease | Status post Therapy

Tipo di dati

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
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrizione

Exclusion Criteria

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

daratumumab | Therapy Against CD38

Tipo di dati

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
Descrizione

Therapy Myeloma

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Malignant Neoplasms | Exception Multiple Myeloma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026764
Ritorna all'inizio della pagina

Similar models

Eligibility Multiple Myeloma NCT02076009

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial