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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01998503
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed AL amyloidosis
* Abnormal M protein or free light chain detected in serum and/or urine
* ECOG score 0-2 points
* No absolute neutrophil count of ANC less than or equal to 1000 within 14 days before enrollment
* No platelet count of less than or equal to 50K within 14 days before enrollment
* Serum bilirubin must lower than 2.0 mg/dl within 14 days before enrollment
* Serum creatinine must lower than 2.0 mg/dl within 14 days before enrollment
* Must have LVEF at least 45% by ECHO within 14 days of enrollment
* Pulmonary Function Tests must show DLCO at least 50%
Exclusion Criteria:
* Subjects have received or are currently receiving systematic treatment with steroids (not including an emergent short-term use of steroids before randomization up to 4 days, maximum dose of 40mg/d)
* Pregnant and breastfeeding women, delivery term women or unwilling to take birth control measures during the study
* Subjects suffering from multiple myeloma
* Grade 2 or more than grade 2 peripheral neuropathy or neuropathic pain according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3
* Known or suspected hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters)
* Subjects suffering from uncontrolled or severe cardiovascular disease, including myocardial infarction, class III-IV heart failure defined by New York Heart Association (NYHA), uncontrolled angina, clinical significant pericardial disease or cardiac amyloidosis (Other contraindications are not suitable for transplant patients) within 6 months before enrollment
* Subjects suffering from serious physical disease and mental illnesses which may interfere the study
* Subjects receiving other pilot study or treatment within 4 weeks before enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01998503
Study Brief:
Protocol Section:
NCT01998503