ID

30884

Beskrivning

Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01045460

Länk

https://clinicaltrials.gov/show/NCT01045460

Nyckelord

Versioner (1)
  1. 2018-07-01 2018-07-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01045460

Engelsk

Eligibility Multiple Myeloma NCT01045460

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
durie-salmon stage ii or iii multiple myeloma
Beskrivning

Multiple Myeloma Durie/Salmon Stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C4528204
newly diagnosed either prior to receiving treatment or having completed induction therapy
Beskrivning

Newly Diagnosed prior to Therapeutic procedure | Induction Therapy Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518321
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0205197
relapsed myeloma not previously transplanted within the past 5 years
Beskrivning

Recurrent multiple myeloma | Transplantation Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C0332197
measurable serum and/or urine m-protein from prior to induction therapy documented and available. a positive serum free lite assay is acceptable
Beskrivning

Availability of Serum M Protein Measurable | Availability of Urine M Protein Measurable | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C0700271
UMLS CUI [1,4]
C1513040
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C0700271
UMLS CUI [2,4]
C1513040
UMLS CUI [3]
C3846158
age greater than 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 - 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
meet all institutional requirements for autologous stem cell transplantation
Beskrivning

Requirement Fulfill Transplantation of autologous hematopoietic stem cell

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1831743
the patient must be able to comprehend and have signed the informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of any of the following plasma cell disorders: poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [m-protein] and skin changes) non-secretory myeloma (no measurable protein on serum free lite assay)
Beskrivning

Plasma cell disorders | POEMS Syndrome | Non-secretory myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C1136084
UMLS CUI [2]
C0085404
UMLS CUI [3]
C0456845
plasma cell leukemia
Beskrivning

Leukemia, Plasma Cell

Datatyp

boolean

Alias
UMLS CUI [1]
C0023484
amyloidosis
Beskrivning

Amyloidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0002726
use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection
Beskrivning

Adrenal Cortex Hormones | Glucocorticoids

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0017710
use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine
Beskrivning

Therapeutic procedure Myeloma Specific | Exception Lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1144149
in a complete remission at the time of bone marrow collection
Beskrivning

In complete remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0677874
infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection
Beskrivning

Communicable Disease Requirement Antibiotics | Communicable Disease Requirement Antifungal Agents | Communicable Disease Requirement Antiviral Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003308
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003451
participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
history of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer
Beskrivning

Malignant Neoplasms | Exception Multiple Myeloma | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. hypothyroidism without evidence of grave's disease or hashimoto's thyroiditis is permitted
Beskrivning

Autoimmune Disease Requirement Systemic therapy | Rheumatoid Arthritis | Multiple Sclerosis | Lupus Erythematosus, Systemic | Hypothyroidism Without Graves Disease allowed | Hypothyroidism Without Hashimoto Disease allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0026769
UMLS CUI [4]
C0024141
UMLS CUI [5,1]
C0020676
UMLS CUI [5,2]
C0332288
UMLS CUI [5,3]
C0018213
UMLS CUI [5,4]
C0683607
UMLS CUI [6,1]
C0020676
UMLS CUI [6,2]
C0332288
UMLS CUI [6,3]
C0677607
UMLS CUI [6,4]
C0683607
evidence of spinal cord compression at time of transplant
Beskrivning

Compression of spinal cord

Datatyp

boolean

Alias
UMLS CUI [1]
C0037926
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Similar models

Eligibility Multiple Myeloma NCT01045460

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Durie/Salmon Stage
Item
durie-salmon stage ii or iii multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C4528204 (UMLS CUI [1,2])
Newly Diagnosed prior to Therapeutic procedure | Induction Therapy Completed
Item
newly diagnosed either prior to receiving treatment or having completed induction therapy
boolean
C1518321 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Recurrent multiple myeloma | Transplantation Absent
Item
relapsed myeloma not previously transplanted within the past 5 years
boolean
C1370446 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Availability of Serum M Protein Measurable | Availability of Urine M Protein Measurable | Other Coding
Item
measurable serum and/or urine m-protein from prior to induction therapy documented and available. a positive serum free lite assay is acceptable
boolean
C0470187 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0700271 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,4])
C0470187 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0700271 (UMLS CUI [2,3])
C1513040 (UMLS CUI [2,4])
C3846158 (UMLS CUI [3])
Age
Item
age greater than 18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Requirement Fulfill Transplantation of autologous hematopoietic stem cell
Item
meet all institutional requirements for autologous stem cell transplantation
boolean
C1514873 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1831743 (UMLS CUI [1,3])
Informed Consent
Item
the patient must be able to comprehend and have signed the informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Plasma cell disorders | POEMS Syndrome | Non-secretory myeloma
Item
diagnosis of any of the following plasma cell disorders: poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [m-protein] and skin changes) non-secretory myeloma (no measurable protein on serum free lite assay)
boolean
C1136084 (UMLS CUI [1])
C0085404 (UMLS CUI [2])
C0456845 (UMLS CUI [3])
Leukemia, Plasma Cell
Item
plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
Amyloidosis
Item
amyloidosis
boolean
C0002726 (UMLS CUI [1])
Adrenal Cortex Hormones | Glucocorticoids
Item
use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection
boolean
C0001617 (UMLS CUI [1])
C0017710 (UMLS CUI [2])
Therapeutic procedure Myeloma Specific | Exception Lenalidomide
Item
use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
In complete remission
Item
in a complete remission at the time of bone marrow collection
boolean
C0677874 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics | Communicable Disease Requirement Antifungal Agents | Communicable Disease Requirement Antiviral Agents
Item
infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003308 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003451 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Malignant Neoplasms | Exception Multiple Myeloma | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Autoimmune Disease Requirement Systemic therapy | Rheumatoid Arthritis | Multiple Sclerosis | Lupus Erythematosus, Systemic | Hypothyroidism Without Graves Disease allowed | Hypothyroidism Without Hashimoto Disease allowed
Item
active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. hypothyroidism without evidence of grave's disease or hashimoto's thyroiditis is permitted
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2])
C0026769 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0020676 (UMLS CUI [5,1])
C0332288 (UMLS CUI [5,2])
C0018213 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
C0020676 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0677607 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
Compression of spinal cord
Item
evidence of spinal cord compression at time of transplant
boolean
C0037926 (UMLS CUI [1])
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