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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