ID

24651

Beschreibung

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

Stichworte

Versionen (1)
  1. 11.08.17 11.08.17 -
Hochgeladen am

11. August 2017

DOI

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Eligibility Multiple Myeloma NCT00784823

Englisch

Eligibility Multiple Myeloma NCT00784823

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Multiple Myeloma

Datentyp

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
Beschreibung

Melphalan Dose intense | Disease Progression | Paraprotein Decrease Percentage

Datentyp

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
Beschreibung

Melphalan Dose intense | Interventional procedure Disease Progression

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Gender

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Syngeneic transplantation preferred

Datentyp

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
Beschreibung

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

Datentyp

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 -
Beschreibung

Salvage Therapy Complication Patient recovered

Datentyp

boolean

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

Exclusion Criteria

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

Diagnosis Except Multiple Myeloma

Datentyp

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
Beschreibung

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

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

Therapeutic procedure Dose intense

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

CNS metastases Uncontrolled

Datentyp

boolean

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

Amyloid deposition Heart

Datentyp

boolean

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

Single organ dysfunction

Datentyp

boolean

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

Left ventricular ejection fraction | Heart failure Unresponsive to Treatment

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased

Datentyp

boolean

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

Creatinine clearance measurement

Datentyp

boolean

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

Sensory neuropathy CTCAE Grades

Datentyp

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
Beschreibung

Karnofsky Performance Status | Bone Disease caused by Myeloma

Datentyp

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
Beschreibung

Comorbidity Life Expectancy Limited

Datentyp

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)
Beschreibung

Cancer in remission | Basal cell carcinoma Excluded

Datentyp

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
Beschreibung

Pregnancy | Contraceptive methods Unwilling

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00784823

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