ID

30867

Beschreibung

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

Stichworte

Versionen (1)
  1. 28.06.18 28.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00800059

Englisch

Eligibility Multiple Myeloma NCT00800059

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

Criteria Fulfill

Datentyp

boolean

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

Refractory multiple myeloma Primary | Recurrent multiple myeloma Primary

Datentyp

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.
Beschreibung

Serum Monoclonal gammopathy Measurable | Urine Monoclonal gammopathy Measurable

Datentyp

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.
Beschreibung

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

Datentyp

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+
Beschreibung

Graft Hematopoietic stem cells Autologous CD34 positive

Datentyp

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.
Beschreibung

Graft CD34 positive Amount Cryopreserved | Graft Available Transplantation

Datentyp

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.
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Criteria Fulfill

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Absence Prior Therapy Multiple Myeloma | Absence Adrenal Cortex Hormones intense

Datentyp

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.
Beschreibung

Life Expectancy Limited Severe | Etiology Comorbidity

Datentyp

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.
Beschreibung

Prior radiation therapy | Cancer Other

Datentyp

boolean

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

Study Subject Participation Status | Compliance behavior Lacking

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00800059

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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