ID

24651

Beschrijving

Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00784823

Link

https://clinicaltrials.gov/show/NCT00784823

Trefwoorden

Versies (1)
  1. 11-08-17 11-08-17 -
Geüploaded op

11 augustus 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Multiple Myeloma NCT00784823

Engels

Eligibility Multiple Myeloma NCT00784823

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a confirmed diagnosis of multiple myeloma
Beschrijving

Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
2. show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
Beschrijving

Melphalan Dose intense | Disease Progression | Paraprotein Decrease Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025241
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0522510
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0700271
UMLS CUI [3,2]
C0547047
UMLS CUI [3,3]
C0439165
may have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
Beschrijving

Melphalan Dose intense | Interventional procedure Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025241
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0522510
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0242656
3. age:18yrs-76yrs at time of melphalan administration
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
4. gender: there is no gender restriction
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
5. availability of >2x10^6 autologous peripheral blood cd34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
Beschrijving

Peripheral blood stem cell Autologous CD34 positive Available | Donor Syngeneic | Donation Syngeneic Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518999
UMLS CUI [1,2]
C0439859
UMLS CUI [1,3]
C0882849
UMLS CUI [1,4]
C0470187
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C2348628
UMLS CUI [3,1]
C0680854
UMLS CUI [3,2]
C2348628
UMLS CUI [3,3]
C0243161
UMLS CUI [3,4]
C1550543
syngeneic transplantation is preferred
Beschrijving

Syngeneic transplantation preferred

Datatype

boolean

Alias
UMLS CUI [1,1]
C0520485
UMLS CUI [1,2]
C0558295
for patients enrolled in the phase i part of this study, >1x10^6 autologous or syngeneic peripheral blood cd34+ cells/kg remaining in storage as "backup" in case of engraftment failure
Beschrijving

Peripheral blood stem cell Autologous CD34 positive Storage | Peripheral blood stem cell Syngeneic CD34 positive Storage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518999
UMLS CUI [1,2]
C0439859
UMLS CUI [1,3]
C0882849
UMLS CUI [1,4]
C1698986
UMLS CUI [2,1]
C1518999
UMLS CUI [2,2]
C2348628
UMLS CUI [2,3]
C0882849
UMLS CUI [2,4]
C1698986
6. recovery from complications of salvage therapy, if administered -
Beschrijving

Salvage Therapy Complication Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C1115804
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosis other than multiple myeloma
Beschrijving

Diagnosis Except Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0026764
2. chemotherapy or radiotherapy within 28 days of initiating treatment in this study
Beschrijving

Chemotherapy | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
3. prior dose-intense therapy within 56 days of initiating treatment in this study
Beschrijving

Therapeutic procedure Dose intense

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0522510
4. uncontrolled bacterial,viral,fungal or parasitic infections
Beschrijving

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Parasitic infection Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0747256
UMLS CUI [4,2]
C0205318
5. uncontrolled cns metastases
Beschrijving

CNS metastases Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
6. known amyloid deposition in heart
Beschrijving

Amyloid deposition Heart

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011560
UMLS CUI [1,2]
C0018787
7. organ dysfunction
Beschrijving

Single organ dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0349410
lvef<40% or cardiac failure not responsive to therapy
Beschrijving

Left ventricular ejection fraction | Heart failure Unresponsive to Treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205269
fvc,fev1,or dlco<50% of predicted and/or receiving supplementary continuous oxygen
Beschrijving

Forced vital capacity | FEV1 | Carbon Monoxide Diffusing Capability Test | Oxygen supplementation

Datatype

boolean

Alias
UMLS CUI [1]
C1287681
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1516251
UMLS CUI [4]
C0919655
evidence of hepatic synthetic dysfunction, or total bilirubin>2x or ast>3x uln
Beschrijving

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
measured creatinine clearance <20ml/min
Beschrijving

Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
sensory peripheral neuropathy grade 4
Beschrijving

Sensory neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
8. karnofsky score<70% unless a result of bone disease directly caused by myeloma
Beschrijving

Karnofsky Performance Status | Bone Disease caused by Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C0005940
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0026764
9. life expectancy limited by another co-morbid illness
Beschrijving

Comorbidity Life Expectancy Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0023671
UMLS CUI [1,3]
C0439801
10. history of another malignancy in remission <2yrs (other than basal cell carcinoma)
Beschrijving

Cancer in remission | Basal cell carcinoma Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0687702
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C2828389
11. pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
Beschrijving

Pregnancy | Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
12. documented hypersensitivity to melphalan or bortezomib or any components of the formulation
Beschrijving

Melphalan allergy | Hypersensitivity Bortezomib | Hypersensitivity Melphalan Component | Hypersensitivity Bortezomib Component

Datatype

boolean

Alias
UMLS CUI [1]
C0570673
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1176309
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0025241
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1176309
UMLS CUI [4,3]
C1705248
13. patients unable or unwilling to provide consent
Beschrijving

Informed Consent Unable | Informed Consent Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
Terug naar het begin van de pagina

Similar models

Eligibility Multiple Myeloma NCT00784823

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
1. a confirmed diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Melphalan Dose intense | Disease Progression | Paraprotein Decrease Percentage
Item
2. show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
boolean
C0025241 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
C0700271 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
Melphalan Dose intense | Interventional procedure Disease Progression
Item
may have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
boolean
C0025241 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Age
Item
3. age:18yrs-76yrs at time of melphalan administration
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. gender: there is no gender restriction
boolean
C0079399 (UMLS CUI [1])
Peripheral blood stem cell Autologous CD34 positive Available | Donor Syngeneic | Donation Syngeneic Criteria Fulfill
Item
5. availability of >2x10^6 autologous peripheral blood cd34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
boolean
C1518999 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
C0040288 (UMLS CUI [2,1])
C2348628 (UMLS CUI [2,2])
C0680854 (UMLS CUI [3,1])
C2348628 (UMLS CUI [3,2])
C0243161 (UMLS CUI [3,3])
C1550543 (UMLS CUI [3,4])
Syngeneic transplantation preferred
Item
syngeneic transplantation is preferred
boolean
C0520485 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
Peripheral blood stem cell Autologous CD34 positive Storage | Peripheral blood stem cell Syngeneic CD34 positive Storage
Item
for patients enrolled in the phase i part of this study, >1x10^6 autologous or syngeneic peripheral blood cd34+ cells/kg remaining in storage as "backup" in case of engraftment failure
boolean
C1518999 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
C1698986 (UMLS CUI [1,4])
C1518999 (UMLS CUI [2,1])
C2348628 (UMLS CUI [2,2])
C0882849 (UMLS CUI [2,3])
C1698986 (UMLS CUI [2,4])
Salvage Therapy Complication Patient recovered
Item
6. recovery from complications of salvage therapy, if administered -
boolean
C0085405 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1115804 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diagnosis Except Multiple Myeloma
Item
1. diagnosis other than multiple myeloma
boolean
C0011900 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Chemotherapy | Therapeutic radiology procedure
Item
2. chemotherapy or radiotherapy within 28 days of initiating treatment in this study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Therapeutic procedure Dose intense
Item
3. prior dose-intense therapy within 56 days of initiating treatment in this study
boolean
C0087111 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Parasitic infection Uncontrolled
Item
4. uncontrolled bacterial,viral,fungal or parasitic infections
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0747256 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
CNS metastases Uncontrolled
Item
5. uncontrolled cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Amyloid deposition Heart
Item
6. known amyloid deposition in heart
boolean
C0011560 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Single organ dysfunction
Item
7. organ dysfunction
boolean
C0349410 (UMLS CUI [1])
Left ventricular ejection fraction | Heart failure Unresponsive to Treatment
Item
lvef<40% or cardiac failure not responsive to therapy
boolean
C0428772 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Forced vital capacity | FEV1 | Carbon Monoxide Diffusing Capability Test | Oxygen supplementation
Item
fvc,fev1,or dlco<50% of predicted and/or receiving supplementary continuous oxygen
boolean
C1287681 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
C0919655 (UMLS CUI [4])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased
Item
evidence of hepatic synthetic dysfunction, or total bilirubin>2x or ast>3x uln
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Creatinine clearance measurement
Item
measured creatinine clearance <20ml/min
boolean
C0373595 (UMLS CUI [1])
Sensory neuropathy CTCAE Grades
Item
sensory peripheral neuropathy grade 4
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Karnofsky Performance Status | Bone Disease caused by Myeloma
Item
8. karnofsky score<70% unless a result of bone disease directly caused by myeloma
boolean
C0206065 (UMLS CUI [1])
C0005940 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Comorbidity Life Expectancy Limited
Item
9. life expectancy limited by another co-morbid illness
boolean
C0009488 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Cancer in remission | Basal cell carcinoma Excluded
Item
10. history of another malignancy in remission <2yrs (other than basal cell carcinoma)
boolean
C0687702 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Pregnancy | Contraceptive methods Unwilling
Item
11. pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Melphalan allergy | Hypersensitivity Bortezomib | Hypersensitivity Melphalan Component | Hypersensitivity Bortezomib Component
Item
12. documented hypersensitivity to melphalan or bortezomib or any components of the formulation
boolean
C0570673 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1176309 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0025241 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C1176309 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
Informed Consent Unable | Informed Consent Unwilling
Item
13. patients unable or unwilling to provide consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial