ID

30868

Beschreibung

Study of ENMD-2076 in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00806065

Link

https://clinicaltrials.gov/show/NCT00806065

Stichworte

Versionen (1)
  1. 29.06.18 29.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Juni 2018

DOI

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Eligibility Multiple Myeloma NCT00806065

Englisch

Eligibility Multiple Myeloma NCT00806065

1 Formulare  
Criteria
Beschreibung

Criteria

1. histological evidence of mm and evidence of relapse or refractory disease. patients with non secretory myeloma or plasmacytoma only will be excluded.
Beschreibung

Multiple Myeloma | Recurrent disease | Refractory Disease | Non-secretory myeloma Excluded | Plasmacytoma Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C0456845
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0032131
UMLS CUI [5,2]
C0332196
2. patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
Beschreibung

Therapeutic procedure failed | Thalidomide | Lenalidomide | Velcade | Intolerance to Thalidomide | Intolerance to Lenalidomide | Intolerance to Velcade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0039736
UMLS CUI [3]
C1144149
UMLS CUI [4]
C1174739
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0039736
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C1144149
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C1174739
3. age ≥18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status 0-2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. patients must have adequate organ and marrow function
Beschreibung

Organ function | Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
major exclusion criteria:
Beschreibung

Exclusion Criteria Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205164
1. prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug enmd-2076.
Beschreibung

Cytotoxic Chemotherapy | Investigational New Drugs | Autologous hematopoietic stem cell transplant | Time Period Receive ENMD 2076

Datentyp

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2193200
UMLS CUI [4,1]
C1948053
UMLS CUI [4,2]
C1514756
UMLS CUI [4,3]
C2703108
2. prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
Beschreibung

Irradiation of pelvis Bone Marrow Percent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0747411
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
3. concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
Beschreibung

Steroid therapy | Prednisone U/day | Dose Equivalent | Management Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0205163
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C0009488
4. have unstable angina pectoris or recent myocardial infarction (within 6 months.
Beschreibung

Angina, Unstable | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
5. have uncontrolled hypertension or congestive heart failure.
Beschreibung

Uncontrolled hypertension | Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0018802
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00806065

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Multiple Myeloma | Recurrent disease | Refractory Disease | Non-secretory myeloma Excluded | Plasmacytoma Excluded
Item
1. histological evidence of mm and evidence of relapse or refractory disease. patients with non secretory myeloma or plasmacytoma only will be excluded.
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C0456845 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0032131 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Therapeutic procedure failed | Thalidomide | Lenalidomide | Velcade | Intolerance to Thalidomide | Intolerance to Lenalidomide | Intolerance to Velcade
Item
2. patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
boolean
C0087111 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0039736 (UMLS CUI [2])
C1144149 (UMLS CUI [3])
C1174739 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0039736 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C1144149 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C1174739 (UMLS CUI [7,2])
Age
Item
3. age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
5. patients must have adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Exclusion Criteria Major
Item
major exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Cytotoxic Chemotherapy | Investigational New Drugs | Autologous hematopoietic stem cell transplant | Time Period Receive ENMD 2076
Item
1. prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug enmd-2076.
boolean
C0677881 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2193200 (UMLS CUI [3])
C1948053 (UMLS CUI [4,1])
C1514756 (UMLS CUI [4,2])
C2703108 (UMLS CUI [4,3])
Irradiation of pelvis Bone Marrow Percent
Item
2. prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis).
boolean
C0747411 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Steroid therapy | Prednisone U/day | Dose Equivalent | Management Comorbidity
Item
3. concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
boolean
C0149783 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0178602 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0376636 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Angina, Unstable | Myocardial Infarction
Item
4. have unstable angina pectoris or recent myocardial infarction (within 6 months.
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Uncontrolled hypertension | Congestive heart failure
Item
5. have uncontrolled hypertension or congestive heart failure.
boolean
C1868885 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
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