Information:
Fel:
ID
45451
Beskrivning
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.
Länk
Nyckelord
Versioner (1)
- 2022-12-10 2022-12-10 - Chiara Middel
Rättsinnehavare
Sagar Lonial, MD, Multiple Myeloma Research Foundation (MMRF), Norwalk, CT and Emory University, Atlanta, GA, USA
Uppladdad den
10 december 2022
DOI
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Licens
Creative Commons BY 4.0
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dbGaP phs000748 Multiple Myeloma CoMMpass Study
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- The subject consent data table includes subject IDs, consent information, subject aliases, and affection status for multiple myeloma (MM).
- The pedigree table includes subject ID, family ID, father and mother ID, and subject's sex.
- The subject sample mapping data table contains mapping of study subject IDs to sample IDs. dbGaP samples are defined as the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes longitudinal sample IDs, sample aliases, sample use, and analysis cohort.
- The sample attributes table includes longitudinal sample ID, body site where sample was collected, analyte type, tumor status, histological type, tumor type, stage, and location, treatment type, genotyping and sequencing centers, and reason for sample collection.
Similar models
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- The subject consent data table includes subject IDs, consent information, subject aliases, and affection status for multiple myeloma (MM).
- The pedigree table includes subject ID, family ID, father and mother ID, and subject's sex.
- The subject sample mapping data table contains mapping of study subject IDs to sample IDs. dbGaP samples are defined as the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes longitudinal sample IDs, sample aliases, sample use, and analysis cohort.
- The sample attributes table includes longitudinal sample ID, body site where sample was collected, analyte type, tumor status, histological type, tumor type, stage, and location, treatment type, genotyping and sequencing centers, and reason for sample collection.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])