ID

30865

Beschrijving

A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00747123

Link

https://clinicaltrials.gov/show/NCT00747123

Trefwoorden

Versies (1)
  1. 28-06-18 28-06-18 -
Houder van rechten

See clinicaltrials.gov

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28 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00747123

Engels

Eligibility Multiple Myeloma NCT00747123

1 Formulieren  
Criteria
Beschrijving

Criteria

patient at least 18 years of age with stage ii or iii multiple myeloma
Beschrijving

Age | Multiple Myeloma Durie/Salmon Stage

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C4528204
one or more lytic bone lesions
Beschrijving

Lytic bone lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221204
UMLS CUI [1,2]
C1265611
if currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1
Beschrijving

Diphosphonates Dose Stable | Diphosphonates Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C0332197
if patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (hsct), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since hsct
Beschrijving

Transplantation of autologous hematopoietic stem cell | Allogeneic Hematopoietic Stem Cell Transplantation | Patient's condition stable

Datatype

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C1705576
UMLS CUI [3]
C1282982
has planned hsct for the duration of the study
Beschrijving

Hemopoietic stem cell transplant Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C1301732
has moles or lesions that are currently undiagnosed, but are suspect for malignancy
Beschrijving

Moles Undiagnosed | Lesion Undiagnosed | Malignant Neoplasms Suspected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027960
UMLS CUI [1,2]
C1408353
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1408353
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0750491
has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate.
Beschrijving

Condition Resulting in Bone metabolism Abnormal | Exception Bone lesion Relationship Malignant Neoplasms | Hyperparathyroidism | Hypoparathyroidism | Hypocalcemia | Rheumatoid Arthritis | Myeloproliferative disease | Gout | Osteitis Deformans | Osteomalacia | Osteoporosis prior to Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0596204
UMLS CUI [1,4]
C0205161
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0238792
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0006826
UMLS CUI [3]
C0020502
UMLS CUI [4]
C0020626
UMLS CUI [5]
C0020598
UMLS CUI [6]
C0003873
UMLS CUI [7]
C0027022
UMLS CUI [8]
C0018099
UMLS CUI [9]
C0029401
UMLS CUI [10]
C0029442
UMLS CUI [11,1]
C0029456
UMLS CUI [11,2]
C0332152
UMLS CUI [11,3]
C0026764
key exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions
Beschrijving

Condition Resulting in Bone metabolism Abnormal | Exception Bone lesion Relationship Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0596204
UMLS CUI [1,4]
C0205161
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0238792
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0006826
history of polyneuropathy ≥ grade 3
Beschrijving

Polyneuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152025
UMLS CUI [1,2]
C1516728
patients with plasma cell leukemia
Beschrijving

Leukemia, Plasma Cell

Datatype

boolean

Alias
UMLS CUI [1]
C0023484
planned stem cell transplant (hsct) or radiation for the duration of the study
Beschrijving

Hemopoietic stem cell transplant Planned | Therapeutic radiology procedure Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1301732
skeletal related event within 2 weeks of study enrollment
Beschrijving

Event Relationship Skeleton

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0816871
has received erythropoiesis-stimulating agents (esas) within the last 21 days or is planned to receive esas during the course of the study
Beschrijving

Erythropoiesis-stimulating Agent | Erythropoiesis-stimulating Agent Planned

Datatype

boolean

Alias
UMLS CUI [1]
C2917382
UMLS CUI [2,1]
C2917382
UMLS CUI [2,2]
C1301732
has received anti-myeloma therapy within the last 21 days
Beschrijving

Therapeutic procedure Against Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0026764
is scheduled to receive local radiation to bone during the course of the study
Beschrijving

Radiotherapy to bone Local Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0948797
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0205539
has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment
Beschrijving

Estrogens | Androgens | Anabolic steroids | Calcitonin | Pharmaceutical Preparations Bone Active

Datatype

boolean

Alias
UMLS CUI [1]
C0014939
UMLS CUI [2]
C0002844
UMLS CUI [3]
C0002845
UMLS CUI [4]
C0006668
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0262950
UMLS CUI [5,3]
C0205177
woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
Beschrijving

Childbearing Potential | Hysterectomy Absent | Postmenopausal state Absent

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
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Similar models

Eligibility Multiple Myeloma NCT00747123

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Age | Multiple Myeloma Durie/Salmon Stage
Item
patient at least 18 years of age with stage ii or iii multiple myeloma
boolean
C0001779 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C4528204 (UMLS CUI [2,2])
Lytic bone lesion Quantity
Item
one or more lytic bone lesions
boolean
C0221204 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Diphosphonates Dose Stable | Diphosphonates Absent
Item
if currently receiving bisphosphonate therapy, have been on a stable dose for ≥ 2 months before dosing day 1 or must not have received bisphosphonates within 2 months of dosing day 1
boolean
C0012544 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0012544 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Transplantation of autologous hematopoietic stem cell | Allogeneic Hematopoietic Stem Cell Transplantation | Patient's condition stable
Item
if patient has undergone previous autologous or allogenic hematopoietic stem cell transplantation (hsct), they must be stable (in the opinion of the investigator) and be a minimum of 6 months since hsct
boolean
C1831743 (UMLS CUI [1])
C1705576 (UMLS CUI [2])
C1282982 (UMLS CUI [3])
Hemopoietic stem cell transplant Planned
Item
has planned hsct for the duration of the study
boolean
C0472699 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Moles Undiagnosed | Lesion Undiagnosed | Malignant Neoplasms Suspected
Item
has moles or lesions that are currently undiagnosed, but are suspect for malignancy
boolean
C0027960 (UMLS CUI [1,1])
C1408353 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1408353 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
Condition Resulting in Bone metabolism Abnormal | Exception Bone lesion Relationship Malignant Neoplasms | Hyperparathyroidism | Hypoparathyroidism | Hypocalcemia | Rheumatoid Arthritis | Myeloproliferative disease | Gout | Osteitis Deformans | Osteomalacia | Osteoporosis prior to Multiple Myeloma
Item
has an underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions, such as a history of hyperparathyroidism, hypoparathyroidism, hypocalcemia, rheumatoid arthritis, myeloproliferative disorder, gout, paget's disease of the bone, or osteomalacia; patients with a diagnosis of osteoporosis prior to multiple myeloma diagnosis are eligible to participate.
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0238792 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
C0020502 (UMLS CUI [3])
C0020626 (UMLS CUI [4])
C0020598 (UMLS CUI [5])
C0003873 (UMLS CUI [6])
C0027022 (UMLS CUI [7])
C0018099 (UMLS CUI [8])
C0029401 (UMLS CUI [9])
C0029442 (UMLS CUI [10])
C0029456 (UMLS CUI [11,1])
C0332152 (UMLS CUI [11,2])
C0026764 (UMLS CUI [11,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Condition Resulting in Bone metabolism Abnormal | Exception Bone lesion Relationship Malignant Neoplasms
Item
known underlying condition that may result in abnormal bone metabolism other than cancer related bone lesions
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0238792 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
Polyneuropathy CTCAE Grades
Item
history of polyneuropathy ≥ grade 3
boolean
C0152025 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Leukemia, Plasma Cell
Item
patients with plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
Hemopoietic stem cell transplant Planned | Therapeutic radiology procedure Planned
Item
planned stem cell transplant (hsct) or radiation for the duration of the study
boolean
C0472699 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Event Relationship Skeleton
Item
skeletal related event within 2 weeks of study enrollment
boolean
C0441471 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0816871 (UMLS CUI [1,3])
Erythropoiesis-stimulating Agent | Erythropoiesis-stimulating Agent Planned
Item
has received erythropoiesis-stimulating agents (esas) within the last 21 days or is planned to receive esas during the course of the study
boolean
C2917382 (UMLS CUI [1])
C2917382 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Therapeutic procedure Against Multiple Myeloma
Item
has received anti-myeloma therapy within the last 21 days
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Radiotherapy to bone Local Scheduled
Item
is scheduled to receive local radiation to bone during the course of the study
boolean
C0948797 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Estrogens | Androgens | Anabolic steroids | Calcitonin | Pharmaceutical Preparations Bone Active
Item
has taken estrogen, androgen, anabolic steroids, calcitonin or other bone-active drugs within 4 months of study enrollment
boolean
C0014939 (UMLS CUI [1])
C0002844 (UMLS CUI [2])
C0002845 (UMLS CUI [3])
C0006668 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0262950 (UMLS CUI [5,2])
C0205177 (UMLS CUI [5,3])
Childbearing Potential | Hysterectomy Absent | Postmenopausal state Absent
Item
woman of childbearing potential (not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
boolean
C3831118 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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