ID

24649

Beschreibung

A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD); ODM derived from: https://clinicaltrials.gov/show/NCT00577668

Link

https://clinicaltrials.gov/show/NCT00577668

Stichworte

Versionen (1)
  1. 11.08.17 11.08.17 -
Hochgeladen am

11. August 2017

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00577668

Englisch

Eligibility Multiple Myeloma NCT00577668

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of histologically documented mm with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
Beschreibung

Multiple Myeloma | Transplantation Twice Scheduled | Autologous Transplantation Scheduled | Recurrent disease | Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C1948050
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C0040736
UMLS CUI [3,2]
C0205539
UMLS CUI [4]
C0277556
UMLS CUI [5]
C1335499
patient has measurable disease in which to capture response.
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
performance status of 2 as per zubroid scale, unless ps of 3-4 based solely on bone pain.
Beschreibung

Zubrod Performance Status | Bone pain Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2,1]
C0151825
UMLS CUI [2,2]
C3714786
patients must have a platelet count 75,000/μl, and an anc of at least 1,000/μl.
Beschreibung

Platelet Count measurement | Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0948762
patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
Beschreibung

Liver function | Transaminase Assay | Bilirubin, direct measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0919834
UMLS CUI [3]
C0201916
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy documented within one week of registration. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Beschreibung

Pregnancy Exclusion | Breast Feeding Exclusion | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
male or female adults of at least 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients must have signed an irb-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy or radiotherapy received within the previous 2 weeks.
Beschreibung

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
significant neurotoxicity, defined as grade > 2 neurotoxicity per nci common toxicity criteria (see appendix).
Beschreibung

Neurotoxicity CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C1516728
platelet count < 75,000/mm3, or anc < 1,000/μl.
Beschreibung

Platelet Count measurement | Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0948762
clinically significant hepatic dysfunction as noted by bilirubin or ast > 3 times the upper normal limit or clinically significant concurrent hepatitis.
Beschreibung

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0019158
new york hospital association (nyha) class iii or class iv heart failure.
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
myocardial infarction within the last 6 months.
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
uncontrolled, active infection requiring iv antibiotics.
Beschreibung

Communicable Disease Uncontrolled | Intravenous antibiotic therapy Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0559680
UMLS CUI [2,2]
C0686904
patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
Beschreibung

Therapeutic procedure Ventricular arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0085612
poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
Beschreibung

Poor hypertension control | Diabetes Mellitus | Illness Serious Interferes with Treatment completion | Mental disorder Interferes with Treatment completion

Datentyp

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0580352
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0580352
pregnant or potential for pregnancy. women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.
Beschreibung

Pregnancy | Gender Fertility | Childbearing Potential Pregnancy Test Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0015895
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C0700589
breast-feeding women may not participate.
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00577668

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Transplantation Twice Scheduled | Autologous Transplantation Scheduled | Recurrent disease | Progressive Disease
Item
history of histologically documented mm with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
boolean
C0026764 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C1948050 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0040736 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
C1335499 (UMLS CUI [5])
Measurable Disease
Item
patient has measurable disease in which to capture response.
boolean
C1513041 (UMLS CUI [1])
Zubrod Performance Status | Bone pain Zubrod Performance Status
Item
performance status of 2 as per zubroid scale, unless ps of 3-4 based solely on bone pain.
boolean
C3714786 (UMLS CUI [1])
C0151825 (UMLS CUI [2,1])
C3714786 (UMLS CUI [2,2])
Platelet Count measurement | Absolute neutrophil count
Item
patients must have a platelet count 75,000/μl, and an anc of at least 1,000/μl.
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Transaminase Assay | Bilirubin, direct measurement
Item
patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
boolean
C0232741 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
Pregnancy Exclusion | Breast Feeding Exclusion | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy documented within one week of registration. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Age
Item
male or female adults of at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
patients must have signed an 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)
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiotherapy received within the previous 2 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Neurotoxicity CTCAE Grades
Item
significant neurotoxicity, defined as grade > 2 neurotoxicity per nci common toxicity criteria (see appendix).
boolean
C0235032 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Platelet Count measurement | Absolute neutrophil count
Item
platelet count < 75,000/mm3, or anc < 1,000/μl.
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Hepatitis
Item
clinically significant hepatic dysfunction as noted by bilirubin or ast > 3 times the upper normal limit or clinically significant concurrent hepatitis.
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
Heart failure New York Heart Association Classification
Item
new york hospital association (nyha) class iii or class iv heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
myocardial infarction within the last 6 months.
boolean
C0027051 (UMLS CUI [1])
Communicable Disease Uncontrolled | Intravenous antibiotic therapy Patient need for
Item
uncontrolled, active infection requiring iv antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0559680 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Therapeutic procedure Ventricular arrhythmia
Item
patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
boolean
C0087111 (UMLS CUI [1,1])
C0085612 (UMLS CUI [1,2])
Poor hypertension control | Diabetes Mellitus | Illness Serious Interferes with Treatment completion | Mental disorder Interferes with Treatment completion
Item
poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
boolean
C0421190 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0580352 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
Pregnancy | Gender Fertility | Childbearing Potential Pregnancy Test Contraceptive methods
Item
pregnant or potential for pregnancy. women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0015895 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Breast Feeding
Item
breast-feeding women may not participate.
boolean
C0006147 (UMLS CUI [1])
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