ID

30861

Beskrivning

Study of Natalizumab in Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00675428

Länk

https://clinicaltrials.gov/show/NCT00675428

Nyckelord

Versioner (1)
  1. 2018-06-27 2018-06-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00675428

Engelsk

Eligibility Multiple Myeloma NCT00675428

1 Formulär  
Criteria
Beskrivning

Criteria

relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an imid® drug (including an analogue).
Beskrivning

Recurrent multiple myeloma | Refractory multiple myeloma | Bortezomib | Immunomodulators | Bortezomib Analogue | Immunomodulator Analogue | Patients Inappropriate Bortezomib | Patients Inappropriate Immunomodulators

Datatyp

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C0278620
UMLS CUI [3]
C1176309
UMLS CUI [4]
C1527392
UMLS CUI [5,1]
C1176309
UMLS CUI [5,2]
C0243071
UMLS CUI [6,1]
C1527392
UMLS CUI [6,2]
C0243071
UMLS CUI [7,1]
C0030705
UMLS CUI [7,2]
C1548788
UMLS CUI [7,3]
C1176309
UMLS CUI [8,1]
C0030705
UMLS CUI [8,2]
C1548788
UMLS CUI [8,3]
C1527392
eastern cooperative oncology group (ecog) performance status ≤2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
corrected calcium <10.6 mg/dl.
Beskrivning

Corrected serum calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0455288
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
candidates for stem cell transplantation willing to undergo transplantation. (subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.)
Beskrivning

Patients Appropriate Stem cell transplant | Transplantation Receive Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1504389
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0600109
autologous stem cell transplantation <3 months post-transplant.
Beskrivning

Transplantation of autologous hematopoietic stem cell | Time Period Post Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2,1]
C1948053
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0040732
prior allogeneic stem cell transplantation.
Beskrivning

Allogeneic Stem Cell Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
nonsecretory myeloma.
Beskrivning

Non-secretory myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0456845
plasma cell leukemia (>2000/µl circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells >100,000/µl), clinical evidence of hyperviscosity syndrome, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (poems), or primary systemic amyloidosis.
Beskrivning

Leukemia, Plasma Cell | Circulating Plasma Cell Differential cell count method Standard | Hyperleukocytosis | White Blood Cell Count procedure | Hyperviscosity syndrome | POEMS Syndrome | Primary Systemic Amyloidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0023484
UMLS CUI [2,1]
C3811668
UMLS CUI [2,2]
C2591490
UMLS CUI [2,3]
C1442989
UMLS CUI [3]
C4324336
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0221030
UMLS CUI [6]
C0085404
UMLS CUI [7]
C0281479
subjects who cannot undergo a brain magnetic resonance imaging (mri) study.
Beskrivning

MRI Receive Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
clinically significant (as determined by the investigator) 12 lead electrocardiogram (ecg) abnormalities, including qtc prolongation (>450 ms in males, >470 ms in females).
Beskrivning

12 lead ECG Abnormality | Prolonged QTc interval | Gender

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C1560305
UMLS CUI [3]
C0079399
note: other protocol defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Tillbaka till toppen

Similar models

Eligibility Multiple Myeloma NCT00675428

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Recurrent multiple myeloma | Refractory multiple myeloma | Bortezomib | Immunomodulators | Bortezomib Analogue | Immunomodulator Analogue | Patients Inappropriate Bortezomib | Patients Inappropriate Immunomodulators
Item
relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an imid® drug (including an analogue).
boolean
C1370446 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
C1176309 (UMLS CUI [3])
C1527392 (UMLS CUI [4])
C1176309 (UMLS CUI [5,1])
C0243071 (UMLS CUI [5,2])
C1527392 (UMLS CUI [6,1])
C0243071 (UMLS CUI [6,2])
C0030705 (UMLS CUI [7,1])
C1548788 (UMLS CUI [7,2])
C1176309 (UMLS CUI [7,3])
C0030705 (UMLS CUI [8,1])
C1548788 (UMLS CUI [8,2])
C1527392 (UMLS CUI [8,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤2.
boolean
C1520224 (UMLS CUI [1])
Corrected serum calcium measurement
Item
corrected calcium <10.6 mg/dl.
boolean
C0455288 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Patients Appropriate Stem cell transplant | Transplantation Receive Willing
Item
candidates for stem cell transplantation willing to undergo transplantation. (subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,3])
C0040732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Transplantation of autologous hematopoietic stem cell | Time Period Post Transplantation
Item
autologous stem cell transplantation <3 months post-transplant.
boolean
C1831743 (UMLS CUI [1])
C1948053 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Allogeneic Stem Cell Transplantation
Item
prior allogeneic stem cell transplantation.
boolean
C2242529 (UMLS CUI [1])
Non-secretory myeloma
Item
nonsecretory myeloma.
boolean
C0456845 (UMLS CUI [1])
Leukemia, Plasma Cell | Circulating Plasma Cell Differential cell count method Standard | Hyperleukocytosis | White Blood Cell Count procedure | Hyperviscosity syndrome | POEMS Syndrome | Primary Systemic Amyloidosis
Item
plasma cell leukemia (>2000/µl circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells >100,000/µl), clinical evidence of hyperviscosity syndrome, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (poems), or primary systemic amyloidosis.
boolean
C0023484 (UMLS CUI [1])
C3811668 (UMLS CUI [2,1])
C2591490 (UMLS CUI [2,2])
C1442989 (UMLS CUI [2,3])
C4324336 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0221030 (UMLS CUI [5])
C0085404 (UMLS CUI [6])
C0281479 (UMLS CUI [7])
MRI Receive Unable
Item
subjects who cannot undergo a brain magnetic resonance imaging (mri) study.
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
12 lead ECG Abnormality | Prolonged QTc interval | Gender
Item
clinically significant (as determined by the investigator) 12 lead electrocardiogram (ecg) abnormalities, including qtc prolongation (>450 ms in males, >470 ms in females).
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1560305 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Eligibility Criteria Study Protocol
Item
note: other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Tillbaka till toppen 

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