ID

30853

Beschreibung

A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00664898

Link

https://clinicaltrials.gov/show/NCT00664898

Stichworte

Versionen (1)
  1. 27.06.18 27.06.18 -
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See clinicaltrials.gov

Hochgeladen am

27. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00664898

Englisch

Eligibility Multiple Myeloma NCT00664898

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
documented pathologic diagnosis of multiple myeloma that has relapsed or failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
Beschreibung

Multiple Myeloma | Recurrent disease | Response failed | Status post Systemic therapy Quantity | Exception Steroid therapy Single

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1515119
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0149783
UMLS CUI [5,3]
C0205171
measurable disease
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
at least one prior systemic therapy other than single-agent corticosteroids
Beschreibung

Systemic therapy Quantity | Exception Adrenal Cortex Hormone Single

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0205171
european union patients must have had prior bone marrow transplant (autologous) or be ineligible for transplant
Beschreibung

Autologous bone marrow transplant | Patients Ineligible Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0194037
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1512714
UMLS CUI [2,3]
C0040732
if previously received bortezomib, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥ 6 months from the start of that therapy
Beschreibung

Bortezomib | Clinical Response | Stable Disease | Interval Progression Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C4055223
UMLS CUI [3]
C0677946
UMLS CUI [4,1]
C1272706
UMLS CUI [4,2]
C0242656
UMLS CUI [4,3]
C0332296
if previously received bortezomib, must have recovered from bortezomib-related toxicities and must have a peripheral neuropathy score of grade ≤ 1, according to the nci ctcae v3.0
Beschreibung

Bortezomib | Toxicity Relationship Bortezomib | Patient recovered | Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1176309
UMLS CUI [3]
C1115804
UMLS CUI [4,1]
C0031117
UMLS CUI [4,2]
C1516728
if applicable, completion of autologous transplant ≥ 12 weeks prior to day 1
Beschreibung

Autologous Transplantation Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040736
UMLS CUI [1,2]
C0205197
discontinuation of previous anticancer or investigational therapy for ≥ 21 days prior to treatment, or ≥ 90 days prior to treatment for previous monoclonal antibody administration
Beschreibung

Cancer treatment Discontinuation | Investigational Therapy Discontinuation | Administration Monoclonal Antibodies Discontinuation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C0003250
UMLS CUI [3,3]
C1444662
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior allogeneic bone marrow transplant
Beschreibung

Allogeneic bone marrow transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0149615
other invasive malignancies within 3 years prior to day 1 except for adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, breast, or prostate; or other cancer of which the patient has been disease-free for ≥
Beschreibung

Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0154088
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
3 years
Beschreibung

ID.12

Datentyp

boolean

prior anaphylactic reaction to human immunoglobulin administration
Beschreibung

Anaphylaxis Immune Globulin (Human)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0358321
symptomatic hyperviscosity syndrome
Beschreibung

Hyperviscosity syndrome Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221030
UMLS CUI [1,2]
C0231220
active infection requiring parenteral antibiotics within 14 days of day 1
Beschreibung

Communicable Disease Requirement Antibiotics Parenteral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [1,4]
C1518896
major surgical procedure or significant traumatic injury within 28 days prior to day 1, or anticipation of need for major surgical procedure during the course of the study
Beschreibung

Major surgery | Traumatic injury | Patient need for Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0679637
clinically significant cardiac dysfunction or other significant organ dysfunction
Beschreibung

Cardiac dysfunction | Organ dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C0349410
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00664898

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma | Recurrent disease | Response failed | Status post Systemic therapy Quantity | Exception Steroid therapy Single
Item
documented pathologic diagnosis of multiple myeloma that has relapsed or failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy)
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0149783 (UMLS CUI [5,2])
C0205171 (UMLS CUI [5,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Systemic therapy Quantity | Exception Adrenal Cortex Hormone Single
Item
at least one prior systemic therapy other than single-agent corticosteroids
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Autologous bone marrow transplant | Patients Ineligible Transplantation
Item
european union patients must have had prior bone marrow transplant (autologous) or be ineligible for transplant
boolean
C0194037 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Bortezomib | Clinical Response | Stable Disease | Interval Progression Free of
Item
if previously received bortezomib, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥ 6 months from the start of that therapy
boolean
C1176309 (UMLS CUI [1])
C4055223 (UMLS CUI [2])
C0677946 (UMLS CUI [3])
C1272706 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Bortezomib | Toxicity Relationship Bortezomib | Patient recovered | Peripheral Neuropathy CTCAE Grades
Item
if previously received bortezomib, must have recovered from bortezomib-related toxicities and must have a peripheral neuropathy score of grade ≤ 1, according to the nci ctcae v3.0
boolean
C1176309 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1176309 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
C0031117 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Autologous Transplantation Completion
Item
if applicable, completion of autologous transplant ≥ 12 weeks prior to day 1
boolean
C0040736 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Cancer treatment Discontinuation | Investigational Therapy Discontinuation | Administration Monoclonal Antibodies Discontinuation
Item
discontinuation of previous anticancer or investigational therapy for ≥ 21 days prior to treatment, or ≥ 90 days prior to treatment for previous monoclonal antibody administration
boolean
C0920425 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1533734 (UMLS CUI [3,1])
C0003250 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Allogeneic bone marrow transplantation
Item
prior allogeneic bone marrow transplant
boolean
C0149615 (UMLS CUI [1])
Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Disease Free of
Item
other invasive malignancies within 3 years prior to day 1 except for adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, breast, or prostate; or other cancer of which the patient has been disease-free for ≥
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0154088 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
ID.12
Item
3 years
boolean
Anaphylaxis Immune Globulin (Human)
Item
prior anaphylactic reaction to human immunoglobulin administration
boolean
C0002792 (UMLS CUI [1,1])
C0358321 (UMLS CUI [1,2])
Hyperviscosity syndrome Symptomatic
Item
symptomatic hyperviscosity syndrome
boolean
C0221030 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Communicable Disease Requirement Antibiotics Parenteral
Item
active infection requiring parenteral antibiotics within 14 days of day 1
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1518896 (UMLS CUI [1,4])
Major surgery | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure or significant traumatic injury within 28 days prior to day 1, or anticipation of need for major surgical procedure during the course of the study
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
Cardiac dysfunction | Organ dysfunction
Item
clinically significant cardiac dysfunction or other significant organ dysfunction
boolean
C3277906 (UMLS CUI [1])
C0349410 (UMLS CUI [2])
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