ID

30867

Beschrijving

Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00800059

Link

https://clinicaltrials.gov/show/NCT00800059

Trefwoorden

Versies (1)
  1. 28-06-18 28-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00800059

Engels

Eligibility Multiple Myeloma NCT00800059

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
a subject must meet all of the following criteria to be eligible for the study. these will be evaluated within the four weeks prior to enrolment.
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject must have primary refractory or relapsed multiple myeloma.
Beschrijving

Refractory multiple myeloma Primary | Recurrent multiple myeloma Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0278620
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1370446
UMLS CUI [2,2]
C0205225
subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
Beschrijving

Serum Monoclonal gammopathy Measurable | Urine Monoclonal gammopathy Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C1136085
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0042036
UMLS CUI [2,2]
C1136085
UMLS CUI [2,3]
C1513040
subject must meet institutional guidelines for autologous hsct with adequate renal, cardiac, pulmonary and hepatic function.
Beschrijving

Transplantation of autologous hematopoietic stem cell Guidelines Fulfill | Renal function | Cardiac function | Pulmonary function | Liver function

Datatype

boolean

Alias
UMLS CUI [1,1]
C1831743
UMLS CUI [1,2]
C0162791
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0231921
UMLS CUI [5]
C0232741
an autologous hematopoietic stem cell graft containing more than 2.5 x 106 cd34+
Beschrijving

Graft Hematopoietic stem cells Autologous CD34 positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332835
UMLS CUI [1,2]
C0018956
UMLS CUI [1,3]
C0439859
UMLS CUI [1,4]
C0882849
cells/kg must be cryopreserved and available for transplantation.
Beschrijving

Graft CD34 positive Amount Cryopreserved | Graft Available Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332835
UMLS CUI [1,2]
C0882849
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0010405
UMLS CUI [2,1]
C0332835
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0040732
subject must be of age more than 18 and less than 60 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subject must have an ecog performance score of 0,1, or 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
subject must have the ability to comply with the protocol visit schedule and other protocol requirements.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject meeting any of the following criteria is not eligible for participation in the study:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject with non-secretory multiple myeloma or any plasma cell disorders other that mm.
Beschrijving

Non-secretory myeloma | Plasma Cell Disease | Exception Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C0032112
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0026764
subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
Beschrijving

Absence Prior Therapy Multiple Myeloma | Absence Adrenal Cortex Hormones intense

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0522510
subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
Beschrijving

Life Expectancy Limited Severe | Etiology Comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0009488
subjects who have previously received radiation treatments or other neoplastic disorders.
Beschrijving

Prior radiation therapy | Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1707251
subjects with a history of non-compliance in other studies.
Beschrijving

Study Subject Participation Status | Compliance behavior Lacking

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
pregnant or lactating female subjects.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Myeloma NCT00800059

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
a subject must meet all of the following criteria to be eligible for the study. these will be evaluated within the four weeks prior to enrolment.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Refractory multiple myeloma Primary | Recurrent multiple myeloma Primary
Item
subject must have primary refractory or relapsed multiple myeloma.
boolean
C0278620 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1370446 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Serum Monoclonal gammopathy Measurable | Urine Monoclonal gammopathy Measurable
Item
subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
boolean
C0229671 (UMLS CUI [1,1])
C1136085 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0042036 (UMLS CUI [2,1])
C1136085 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
Transplantation of autologous hematopoietic stem cell Guidelines Fulfill | Renal function | Cardiac function | Pulmonary function | Liver function
Item
subject must meet institutional guidelines for autologous hsct with adequate renal, cardiac, pulmonary and hepatic function.
boolean
C1831743 (UMLS CUI [1,1])
C0162791 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
Graft Hematopoietic stem cells Autologous CD34 positive
Item
an autologous hematopoietic stem cell graft containing more than 2.5 x 106 cd34+
boolean
C0332835 (UMLS CUI [1,1])
C0018956 (UMLS CUI [1,2])
C0439859 (UMLS CUI [1,3])
C0882849 (UMLS CUI [1,4])
Graft CD34 positive Amount Cryopreserved | Graft Available Transplantation
Item
cells/kg must be cryopreserved and available for transplantation.
boolean
C0332835 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0010405 (UMLS CUI [1,4])
C0332835 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Age
Item
subject must be of age more than 18 and less than 60 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
subject must have an ecog performance score of 0,1, or 2.
boolean
C1520224 (UMLS CUI [1])
Protocol Compliance
Item
subject must have the ability to comply with the protocol visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
a subject meeting any of the following criteria is not eligible for participation in the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-secretory myeloma | Plasma Cell Disease | Exception Multiple Myeloma
Item
subject with non-secretory multiple myeloma or any plasma cell disorders other that mm.
boolean
C0456845 (UMLS CUI [1])
C0032112 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
Absence Prior Therapy Multiple Myeloma | Absence Adrenal Cortex Hormones intense
Item
subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
boolean
C0332197 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0522510 (UMLS CUI [2,3])
Life Expectancy Limited Severe | Etiology Comorbidity
Item
subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
Prior radiation therapy | Cancer Other
Item
subjects who have previously received radiation treatments or other neoplastic disorders.
boolean
C0279134 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
Study Subject Participation Status | Compliance behavior Lacking
Item
subjects with a history of non-compliance in other studies.
boolean
C2348568 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating female subjects.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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