ID

45451

Description

Principal Investigator: Sagar Lonial, MD, Multiple Myeloma Research Foundation (MMRF), Norwalk, CT and Emory University, Atlanta, GA, USA MeSH: Multiple Myeloma,Neoplasms, Plasma Cell https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000748 The Multiple Myeloma Research Foundation (MMRF) CoMMpass (Relating *C*linical *O*utcomes in *MM* to *P*ersonal *Ass*essment of Genetic Profile) trial (NCT01454297) is a longitudinal observation study of 1000 newly diagnosed myeloma patients receiving various standard approved treatments that aim at collecting tissue samples, genetic information, Quality of Life (QoL) and various disease and clinical outcomes over 10 years.

Link

dbGaP-study=phs000748

Keywords

Versions (1)
  1. 12/10/22 12/10/22 - Chiara Middel
Copyright Holder

Sagar Lonial, MD, Multiple Myeloma Research Foundation (MMRF), Norwalk, CT and Emory University, Atlanta, GA, USA

Uploaded on

December 10, 2022

DOI

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License

Creative Commons BY 4.0
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dbGaP phs000748 Multiple Myeloma CoMMpass Study

English

Eligibility Criteria

5 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
The treatment regimen selected for the patient is at the discretion of the treating investigator. However, the initial regimen must contain an FDA-approved IMiD® and/or a proteasome inhibitor. Other than this requirement, the study does not dictate dose, schedule or any other specific treatment requirement.
Description

Elig.phs000748.v7.p4.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1521895
UMLS CUI [2,1]
C0205265
UMLS CUI [2,2]
C0040808
UMLS CUI [2,3]
C4763587
UMLS CUI [3,1]
C0205265
UMLS CUI [3,2]
C0040808
UMLS CUI [3,3]
C1443643
*Inclusion Criteria:*
Description

Elig.phs000748.v7.p4.2

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
Patient is at least 18 years old.
Description

Elig.phs000748.v7.p4.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:
Description

Elig.phs000748.v7.p4.4

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0026764
UMLS CUI [1,3]
C0231220
UMLS CUI [1,4]
C1513041
Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (< 0.26 or > 1.65).
Description

Elig.phs000748.v7.p4.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [2,1]
C0042036
UMLS CUI [2,2]
C0700271
UMLS CUI [3,1]
C4744879
UMLS CUI [4,1]
C2826181
The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
Description

Elig.phs000748.v7.p4.6

Data type

boolean

Alias
UMLS CUI [1,1]
C4524864
UMLS CUI [1,2]
C1527392
UMLS CUI [1,3]
C0039736
UMLS CUI [1,4]
C2347624
UMLS CUI [1,5]
C1144149
UMLS CUI [2,1]
C4524864
UMLS CUI [2,2]
C1443643
UMLS CUI [2,3]
C1176309
UMLS CUI [2,4]
C2001856
No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
Description

Elig.phs000748.v7.p4.7

Data type

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0439092
UMLS CUI [1,4]
C3816446
UMLS CUI [1,5]
C0439228
UMLS CUI [1,6]
C0005954
Patient has read, understood and signed informed consent.
Description

Elig.phs000748.v7.p4.8

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
*Exclusion Criteria:*
Description

Elig.phs000748.v7.p4.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
Description

Elig.phs000748.v7.p4.10

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0205171
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0012544
UMLS CUI [2,5]
C0011777
UMLS CUI [2,6]
C0205163
UMLS CUI [2,7]
C2825233
Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
Description

Elig.phs000748.v7.p4.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205451
UMLS CUI [1,3]
C0439234
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0851140
Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.
Description

Elig.phs000748.v7.p4.12

Data type

boolean

Alias
UMLS CUI [1,1]
C4041024
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C4041024
UMLS CUI [2,4]
C0549178
UMLS CUI [2,5]
C0444454
UMLS CUI [2,6]
C1511726
UMLS CUI [2,7]
C0040300
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Similar models

Eligibility Criteria

5 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs000748.v7.p4.1
Item
The treatment regimen selected for the patient is at the discretion of the treating investigator. However, the initial regimen must contain an FDA-approved IMiD® and/or a proteasome inhibitor. Other than this requirement, the study does not dictate dose, schedule or any other specific treatment requirement.
boolean
C0040808 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C0205265 (UMLS CUI [2,1])
C0040808 (UMLS CUI [2,2])
C4763587 (UMLS CUI [2,3])
C0205265 (UMLS CUI [3,1])
C0040808 (UMLS CUI [3,2])
C1443643 (UMLS CUI [3,3])
Elig.phs000748.v7.p4.2
Item
*Inclusion Criteria:*
boolean
C1512693 (UMLS CUI [1,1])
Elig.phs000748.v7.p4.3
Item
Patient is at least 18 years old.
boolean
C0001779 (UMLS CUI [1,1])
Elig.phs000748.v7.p4.4
Item
Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:
boolean
C0011900 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C1513041 (UMLS CUI [1,4])
Elig.phs000748.v7.p4.5
Item
Serum M protein ≥ 1g/dl Urine M protein ≥ 200 mg/24 hrs Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (< 0.26 or > 1.65).
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0042036 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C4744879 (UMLS CUI [3,1])
C2826181 (UMLS CUI [4,1])
Elig.phs000748.v7.p4.6
Item
The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
boolean
C4524864 (UMLS CUI [1,1])
C1527392 (UMLS CUI [1,2])
C0039736 (UMLS CUI [1,3])
C2347624 (UMLS CUI [1,4])
C1144149 (UMLS CUI [1,5])
C4524864 (UMLS CUI [2,1])
C1443643 (UMLS CUI [2,2])
C1176309 (UMLS CUI [2,3])
C2001856 (UMLS CUI [2,4])
Elig.phs000748.v7.p4.7
Item
No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
boolean
C1704686 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0439092 (UMLS CUI [1,3])
C3816446 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,5])
C0005954 (UMLS CUI [1,6])
Elig.phs000748.v7.p4.8
Item
Patient has read, understood and signed informed consent.
boolean
C0021430 (UMLS CUI [1,1])
Elig.phs000748.v7.p4.9
Item
*Exclusion Criteria:*
boolean
C0680251 (UMLS CUI [1,1])
Elig.phs000748.v7.p4.10
Item
Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
boolean
C1515119 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0012544 (UMLS CUI [2,4])
C0011777 (UMLS CUI [2,5])
C0205163 (UMLS CUI [2,6])
C2825233 (UMLS CUI [2,7])
Elig.phs000748.v7.p4.11
Item
Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
boolean
C0006826 (UMLS CUI [1,1])
C0205451 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
Elig.phs000748.v7.p4.12
Item
Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.
boolean
C4041024 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C4041024 (UMLS CUI [2,3])
C0549178 (UMLS CUI [2,4])
C0444454 (UMLS CUI [2,5])
C1511726 (UMLS CUI [2,6])
C0040300 (UMLS CUI [2,7])
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