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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01318902
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants 18 years or older
* Biopsy-proven systemic relapsed or refractory light-chain (AL) amyloidosis, which after at least 1 prior therapy, in the investigator's opinion, requires further treatment
* If received stem cell transplant, must be at least 3 months posttransplantation and recovered from side effects
* Must have measurable disease defined as serum differential free light chain concentration ≥ 40 mg/L
* Must have objective measurable organ (heart or kidney) amyloid involvement
* Must have cardiac biomarker risk stage I or II disease
* Must have adequate hematologic, hepatic, and renal function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Female participants who are postmenopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
* Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
* Voluntary written consent
Exclusion Criteria
* Peripheral neuropathy that is greater or equal to Grade 2
* Cardiac status as described in protocol
* Severe diarrhea (≥ Grade 3) not controllable with medication or requires administration of total parenteral nutrition
* Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of MLN9708
* Uncontrolled infection requiring systematic antibiotics
* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
* Presence of other active malignancy with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limit, or any completely resected carcinoma in situ
* Female participants who are lactating or pregnant
* Major surgery within 14 days before the first dose of study drug
* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01318902
Study Brief:
Protocol Section:
NCT01318902