First line treatment Multiple Myeloma | Requirement Initially Systemic therapy | Chemotherapy Dose conventional | Chemotherapy High dose | Transplantation of autologous hematopoietic stem cell | Consolidation therapy | Consolidation therapy Absent
Item
1. mm which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
boolean
C1708063 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C1515119 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0439858 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C1831743 (UMLS CUI [5])
C1511484 (UMLS CUI [6])
C1511484 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Residual disease Evaluable
Item
2. residual disease considered as evaluable with:
boolean
C0543478 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
Serum M Protein Measurement | Exception m-spike Beta Globulin Area
Item
quantifiable serum m-protein: ≥ 3 g/l, except for spike in the beta globulin area. in this particular case serum m-protein is considered quantifiable if ≥
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0241988 (UMLS CUI [2,2])
C0005157 (UMLS CUI [2,3])
C0205146 (UMLS CUI [2,4])
Serum M Protein Measurement | Free Immunoglobulin Light Chain Involved Measurement | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
if serum m-protein is < 3g/l, measurable involved free light chains ≥ 100 mg/l and an abnormal free light chains ratio (<0.26 or > 1.65)
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0806492 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
C2826181 (UMLS CUI [3])
Disease Response | Partial response | Very Good Partial Response | Response Plateau
Item
3. responses which are partial (pr and vgpr) and in plateau
boolean
C1704632 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C4053871 (UMLS CUI [3])
C1704632 (UMLS CUI [4,1])
C2964353 (UMLS CUI [4,2])
Partial response Criteria | Serum M Protein Percentage Reduction | Status pre- First line Chemotherapy | M Protein Percentage Reduction 24 Hour Urine Test
Item
partial response should meet the imwg uniform response criteria: a ≥ 50% reduction from value of serum m-protein before the first line chemotherapy treatment and a reduction in 24h urinary m-protein by ≥ 90% or to < 200 mg /24h;
boolean
C1521726 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0392756 (UMLS CUI [2,4])
C0332152 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0700271 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0392756 (UMLS CUI [4,3])
C1255149 (UMLS CUI [4,4])
Very Good Partial Response Criteria | Serum M Protein Percentage Reduction | M Protein Level 24 Hour Urine Test | m-spike Gamma globulin Area
Item
very good partial response according to the imwg uniform response criteria with 90% or greater reduction in serum m-protein plus urine m-protein level < 100 mg/24h; furthermore the m-protein should spike in the gamma globulin area;
boolean
C4053871 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0392756 (UMLS CUI [2,4])
C0700271 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C1255149 (UMLS CUI [3,3])
C0241988 (UMLS CUI [4,1])
C0017007 (UMLS CUI [4,2])
C0205146 (UMLS CUI [4,3])
Plateau Phase Definition
Item
plateau phase is defined by :
boolean
C2964353 (UMLS CUI [1,1])
C0205390 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
Serum M Protein Measurement | Serum M Protein Level Stable
Item
for patients with serum m-protein ≥ 3g/l: stable levels of m-protein in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. fluctuations of ± 25 % and ± 2 g/l in serum m-protein levels are allowed.
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Serum M Protein Measurement | Serum Free Immunoglobulin Light Chain Level Stable
Item
for patients with serum m-protein < 3g/l: stable levels free light chains in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. fluctuations of ± 25 % of involved serum free light chain are allowed.
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0229671 (UMLS CUI [2,1])
C0806492 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
ECOG performance status
Item
4. ecog performance status of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results
Item
5. clinical laboratory values at screening:
boolean
C1254595 (UMLS CUI [1])
Creatinine clearance MDRD
Item
calculated creatinine clearance (according to mdrd) > 50 ml/min
boolean
C0812399 (UMLS CUI [1,1])
C3839656 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelet > 50 x 109 /l
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
anc > 1 x 109 /l
boolean
C0948762 (UMLS CUI [1])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
bilirubin levels < 1.5 uln; alt and ast < 2.5 uln
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Gender Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier | Spermicidal Jelly
Item
6. male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, iucd, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C2985330 (UMLS CUI [5])
Informed Consent
Item
7. signed inform consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Age
Item
1. age < 18 years old or > 75 years old
boolean
C0001779 (UMLS CUI [1])
Consolidation therapy | Maintenance therapy | Immunomodulators | Thalidomide | Lenalidomide | Bortezomib
Item
2. previous consolidation/ maintenance therapy by imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
boolean
C1511484 (UMLS CUI [1])
C0677908 (UMLS CUI [2])
C1527392 (UMLS CUI [3])
C0039736 (UMLS CUI [4])
C1144149 (UMLS CUI [5])
C1176309 (UMLS CUI [6])
Chemotherapy | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
3. treatment with chemotherapy, systemic corticosteroid within the previous 2 months
boolean
C0392920 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Growth Factor | Epo | G-CSF | GM-CSF
Item
4. treatment with growth factors (epo, g- or gm-csf) within the previous 1 month
boolean
C0018284 (UMLS CUI [1])
C0014822 (UMLS CUI [2])
C0079459 (UMLS CUI [3])
C0079460 (UMLS CUI [4])
Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Lesion Visceral
Item
5. radiotherapy for bone or visceral lesion within the last 3 months
boolean
C1522449 (UMLS CUI [1,1])
C0238792 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0442045 (UMLS CUI [2,3])
Investigational New Drugs
Item
6. use of any investigational agent within the last 2 months
boolean
C0013230 (UMLS CUI [1])
Primary amyloidosis | Amyloidosis Associated
Item
7. primary or associated amyloidosis
boolean
C0268381 (UMLS CUI [1])
C0002726 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
8. peripheral neuropathy of grade ≥ iii according to the ctcae of the nci
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cardiac Status Abnormal
Item
9. abnormal cardiac status with any of the following
boolean
C1999091 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
1. nyha stage iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
2. myocardial infarction within the previous 6 months
boolean
C0027051 (UMLS CUI [1])
Cardiac Arrhythmia Symptomatic | Therapeutic procedure Resistant
Item
3. symptomatic cardiac arrhythmia despite treatment
boolean
C0003811 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Communicable Disease | HIV Seropositivity | Serology positive Hepatitis C virus | Hepatitis B surface antigen positive
Item
10. current active infectious disease or positive serology for hiv, hcv or positive hbs antigen
boolean
C0009450 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0242089 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
Autoimmune Disease
Item
11. history of or current auto-immune disease
boolean
C0004364 (UMLS CUI [1])
Comorbidity Serious Uncontrolled
Item
12. serious concurrent uncontrolled medical disorder
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
13. history of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Allogeneic Hematopoietic Stem Cell Transplantation | Solid organ transplant
Item
14. history of allogenic hematopoietic cell or solid organ transplantation
boolean
C1705576 (UMLS CUI [1])
C0730400 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
15. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Inconsistent Study Subject Participation Status
Item
16. any medical condition which is regarded by the investigator as incompatible with the study participation
boolean
C3843040 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
17. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])