ID

30880

Description

Compassionate Use Study of Carfilzomib; ODM derived from: https://clinicaltrials.gov/show/NCT00999414

Link

https://clinicaltrials.gov/show/NCT00999414

Keywords

Versions (1)
  1. 6/30/18 6/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00999414

English

Eligibility Multiple Myeloma NCT00999414

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must have histologically documented multiple myeloma which is relapsing or resistant after stem cell transplantation, or when other conventional therapies have failed or are contraindicated
Description

Recurrent multiple myeloma | Refractory multiple myeloma | Status post Stem cell transplant | Conventional Treatment failed | Medical contraindication Conventional Treatment

Data type

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C0278620
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1504389
UMLS CUI [4,1]
C2945704
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C2945704
serum creatinine < 3.0 mg/dl or calculated creatinine clearance >15 ml/min calculated or measured clearance is ≥15 ml/min
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0373595
anc > 1000/mm3 (may be supported with growth factors)
Description

Absolute neutrophil count | Growth Factor Support

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C0018284
UMLS CUI [2,2]
C1521721
platelet count > 30,000/mm3 (may receive transfusion)
Description

Platelet Count measurement | Platelet Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0086818
female participant of child-bearing potential has agreed to use dual methods of contraception for the duration of the study
Description

Childbearing Potential Contraceptive methods Double

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205173
male participant has agreed to use a barrier method of contraception if sexually active with a female of child-bearing potential
Description

Gender Barrier Contraception | Gender Sexually active Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C3831118
patients must have signed and irb-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection requiring systemic treatment
Description

Communicable Disease Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
requires concomitant use of approved or investigative anticancer therapeutic treatment with activity against multiple myeloma, other than dexamethasone
Description

Cancer treatment Multiple Myeloma | Cancer treatment Investigational Multiple Myeloma | Exception Dexamethasone

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0026764
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011777
concomitant use of other investigative agents (e.g., antibiotics or antiemetics)
Description

Investigational New Drugs | Antibiotics | Antiemetics

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0003232
UMLS CUI [3]
C0003297
pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Multiple Myeloma NCT00999414

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent multiple myeloma | Refractory multiple myeloma | Status post Stem cell transplant | Conventional Treatment failed | Medical contraindication Conventional Treatment
Item
participants must have histologically documented multiple myeloma which is relapsing or resistant after stem cell transplantation, or when other conventional therapies have failed or are contraindicated
boolean
C1370446 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1504389 (UMLS CUI [3,2])
C2945704 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C2945704 (UMLS CUI [5,2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
serum creatinine < 3.0 mg/dl or calculated creatinine clearance >15 ml/min calculated or measured clearance is ≥15 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Absolute neutrophil count | Growth Factor Support
Item
anc > 1000/mm3 (may be supported with growth factors)
boolean
C0948762 (UMLS CUI [1])
C0018284 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
Platelet Count measurement | Platelet Transfusion
Item
platelet count > 30,000/mm3 (may receive transfusion)
boolean
C0032181 (UMLS CUI [1])
C0086818 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Double
Item
female participant of child-bearing potential has agreed to use dual methods of contraception for the duration of the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
Gender Barrier Contraception | Gender Sexually active Childbearing Potential
Item
male participant has agreed to use a barrier method of contraception if sexually active with a female of child-bearing potential
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
patients must have signed and irb-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Requirement Systemic therapy
Item
active infection requiring systemic treatment
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Cancer treatment Multiple Myeloma | Cancer treatment Investigational Multiple Myeloma | Exception Dexamethasone
Item
requires concomitant use of approved or investigative anticancer therapeutic treatment with activity against multiple myeloma, other than dexamethasone
boolean
C0920425 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0011777 (UMLS CUI [3,2])
Investigational New Drugs | Antibiotics | Antiemetics
Item
concomitant use of other investigative agents (e.g., antibiotics or antiemetics)
boolean
C0013230 (UMLS CUI [1])
C0003232 (UMLS CUI [2])
C0003297 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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