ID

30861

Description

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

Link

https://clinicaltrials.gov/show/NCT00675428

Keywords

Versions (1)
  1. 6/27/18 6/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00675428

English

Eligibility Multiple Myeloma NCT00675428

1 forms  
Criteria
Description

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).
Description

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

Data type

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.
Description

ECOG performance status

Data type

boolean

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

Corrected serum calcium measurement

Data type

boolean

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

Exclusion Criteria Main

Data type

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.)
Description

Patients Appropriate Stem cell transplant | Transplantation Receive Willing

Data type

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.
Description

Transplantation of autologous hematopoietic stem cell | Time Period Post Transplantation

Data type

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.
Description

Allogeneic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C2242529
nonsecretory myeloma.
Description

Non-secretory myeloma

Data type

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.
Description

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

Data type

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.
Description

MRI Receive Unable

Data type

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).
Description

12 lead ECG Abnormality | Prolonged QTc interval | Gender

Data type

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.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Multiple Myeloma NCT00675428

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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