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])