ID

21880

Beschreibung

An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00216697

Link

https://clinicaltrials.gov/show/NCT00216697

Stichworte

Versionen (1)
  1. 05.05.17 05.05.17 -
Hochgeladen am

5. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00216697

Englisch

Eligibility Multiple Myeloma NCT00216697

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
complete 6 cycles treatment in preceding phase i/ii study
Beschreibung

Therapeutic procedure Quantity Completed | Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
response (cr, pr, mr or nc) was obtained in 6 cycles treatment during the preceding phase i/ii study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
Beschreibung

Therapeutic procedure Quantity | Response In complete remission | Partial response | Minimal therapeutic response | Response No change | Effect Against Neoplasm | Pain relief | Performance status Improved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0677874
UMLS CUI [3]
C1521726
UMLS CUI [4]
C0184783
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0442739
UMLS CUI [6,1]
C1280500
UMLS CUI [6,2]
C0521124
UMLS CUI [6,3]
C0027651
UMLS CUI [7]
C0451615
UMLS CUI [8,1]
C1518965
UMLS CUI [8,2]
C0184511
patients who did not have grade >=3 non-hematologic toxicity or grade 4 hematologic toxicity during the preceding phase i/ii study or extension treatment of this study
Beschreibung

Toxicity CTCAE Grades | Toxicity hematologic CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205488
UMLS CUI [2,3]
C1516728
investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
Beschreibung

Investigational New Drug Benefit Expected | Effect Against Neoplasm | Pain relief | Performance status Improved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C1280500
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0027651
UMLS CUI [3]
C0451615
UMLS CUI [4,1]
C1518965
UMLS CUI [4,2]
C0184511
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is known to be hbs antigen positive, hcv antibody positive or hiv antibody positive (check is required for patients who received blood product during phase i/ii study)
Beschreibung

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive | Blood product Requirement Check

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C1283174
patients who receive g-csf product or blood transfusion within 7 days before the start of treatment
Beschreibung

Granulocyte Colony-Stimulating Factor | Blood Transfusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0005841
disease progress was observed during the phase i/ii or this study when patients receive recommended dose
Beschreibung

Investigational New Drug Dose Recommended | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0034866
UMLS CUI [2]
C0242656
patients who suffer grade >=2 peripheral neuropathy or grade >=2 neuropathic pain
Beschreibung

Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C3714625
UMLS CUI [2,2]
C1516728
patient has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
Beschreibung

Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe | Ischemia | Conduction system abnormalities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0421196
UMLS CUI [3,1]
C0085612
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0205082
UMLS CUI [4]
C0022116
UMLS CUI [5]
C0151236
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00216697

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Quantity Completed | Clinical Trial Specified
Item
complete 6 cycles treatment in preceding phase i/ii study
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Therapeutic procedure Quantity | Response In complete remission | Partial response | Minimal therapeutic response | Response No change | Effect Against Neoplasm | Pain relief | Performance status Improved
Item
response (cr, pr, mr or nc) was obtained in 6 cycles treatment during the preceding phase i/ii study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3])
C0184783 (UMLS CUI [4])
C1704632 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
C1280500 (UMLS CUI [6,1])
C0521124 (UMLS CUI [6,2])
C0027651 (UMLS CUI [6,3])
C0451615 (UMLS CUI [7])
C1518965 (UMLS CUI [8,1])
C0184511 (UMLS CUI [8,2])
Toxicity CTCAE Grades | Toxicity hematologic CTCAE Grades
Item
patients who did not have grade >=3 non-hematologic toxicity or grade 4 hematologic toxicity during the preceding phase i/ii study or extension treatment of this study
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Investigational New Drug Benefit Expected | Effect Against Neoplasm | Pain relief | Performance status Improved
Item
investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
boolean
C0013230 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C1280500 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0451615 (UMLS CUI [3])
C1518965 (UMLS CUI [4,1])
C0184511 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive | Blood product Requirement Check
Item
patient is known to be hbs antigen positive, hcv antibody positive or hiv antibody positive (check is required for patients who received blood product during phase i/ii study)
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
C0456388 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1283174 (UMLS CUI [4,3])
Granulocyte Colony-Stimulating Factor | Blood Transfusion
Item
patients who receive g-csf product or blood transfusion within 7 days before the start of treatment
boolean
C0079459 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
Investigational New Drug Dose Recommended | Disease Progression
Item
disease progress was observed during the phase i/ii or this study when patients receive recommended dose
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Neuropathic pain CTCAE Grades
Item
patients who suffer grade >=2 peripheral neuropathy or grade >=2 neuropathic pain
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C3714625 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe | Ischemia | Conduction system abnormalities
Item
patient has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0421196 (UMLS CUI [2])
C0085612 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0022116 (UMLS CUI [4])
C0151236 (UMLS CUI [5])
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