Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT03759093
Eligibility Criteria:
Inclusion Criteria:
1. Multiple myeloma diagnosed according to standard criteria, without prior anti-myeloma treatment at study entry. Both transplant eligible and ineligible patients may be included.
2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
1. Serum M-protein ≥ 0.5g/dL, or
2. In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) \> 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
3. Males and females ≥ 18 years of age or \> country's legal age for adult consent
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
5. Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
1. Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is \>50%)
2. Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
3. Calculated creatinine clearance ≥ 30mL/min or creatinine \< 3mg/dL.
6. Written informed consent in accordance with federal, local and institutional guidelines
Exclusion Criteria:
1. Female patients who are lactating or pregnant
2. Multiple Myeloma of IgM subtype
3. Glucocorticoid therapy (prednisolone \> 30mg/day or equivalent) within 14 days prior to informed consent obtained
4. POEMS syndrome
5. Plasma cell leukaemia or circulating plasma cells ≥ 2 x 109/L
6. Waldenstrom's Macroglobulinaemia
7. Patients with known amyloidosis
8. Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting bortezomib treatment
9. Focal radiation therapy within 7 days prior to start of treatment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of treatment
10. Immunotherapy (excluding steroids) 21 days prior to start of treatment
11. Major surgery (excluding kyphoplasty) within 28 days prior to start of treatment
12. Active congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
13. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
14. Patients with known cirrhosis
15. Second malignancy within the past 3 years except:
1. Adequately treated basal cell or squamous cell skin cancer
2. Carcinoma in situ of the cervix
3. Breast carcinoma in situ with full surgical resection
16. Patients with myelodysplastic syndrome
17. Patients with steroid, cyclophosphamide, bortezomib, lenalidomide or thalidomide hypersensitivity
18. Patients with a calculated creatinine clearance less than 30ml/min by the Cockroft Galt method.
19. Prior treatment with Bortezomib
20. Contraindication to any of the required concomitant drugs or supportive treatments
21. Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT03759093
Study Brief:
Protocol Section:
NCT03759093