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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04115956
Eligibility Criteria:
Inclusion Criteria: (For full list of inclusion criteria, see study protocol)
* Male or female, age 18 years or older at the time of signing the informed consent
* Proven histochemical diagnosis of AL amyloidosis based on tissue specimens with Congo red staining
* At least one prior line of therapy, defined as either one non-transplant regimen, one ASCT (autologous stem cell transplantation), or one regimen of induction therapy followed by a single ASCT. No more that 4 cycles of melphalan containing chemotherapy is allowed.
* Measurable hematologic disease
* Objectively measurable organ amyloid involvement
* ECOG performance status ≤ 2 (ECOG = Eastern cooperative oncology group)
* Women of child bearing potential must have a negative serum or urine pregnancy test
* Less than 30% plasma cells in bone marrow aspirate or biopsy
* Acceptable laboratory results met (absolute neutrophil count (ANC), platelet count, hemoglobin, total bilirubin,alkaline phosphatase, AST (aspartate aminotransferase) and ALT (alanine aminotransferase), renal function)
* Male participant agrees to use contraception during treatment and 90 days after last dose of melflufen
Exclusion Criteria: (For full list of exclusion criteria, see study protocol)
* Amyloidosis due to known mutations of the transthyretin gene or presence of another non-AL amyloidosis
* Evidence of gastro-intestinal bleeding
* Cardiac risk stage 3
* Low platelets value with evidence of mucosal or internal bleeding
* Medical documented cardiac syncope, NYHA Class 3 or 4 congestive heart failure, myocardial infarction, unstable angina pectoris, clinically significant ventricular arrhythmias (NYHA=New York Heart Association Functional Classification)
* Clinically significant finding on 24 h Holter recording
* Severe orthostatic hypotension
* Clinically significant factor X deficiency
* Clinically significant autonomic disease
* Any medical condition that would impose excessive risk to the patient
* Serious psychiatric illness, active alcoholism or drug addiction that may hinder or confuse compliance
* Known HIV or active hepatitis B or C viral infections
* Previous cytotoxic therapies, including cytotoxic investigational agents within 3 weeks prior to start of study treatment. Monoclonal antibodies within 4 weeks. Concomitant immunotherapy, investigational therapy and anticoagulation therapy are not permitted
* Prior autologous or allogenic stem cell transplant within 12 weeks of initiation of therapy
* Prior allogeneic stem cell transplant with active graft-host-disease
* Prior major surgical procedure or radiation therapy within 4 weeks of the first dose of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04115956
Study Brief:
Protocol Section:
NCT04115956