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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01217957
Eligibility Criteria:
Inclusion Criteria:
Each patient must meet all of the following eligibility criteria to be enrolled in the study:
* Male or female patients 18 years or older
* Previously untreated multiple myeloma diagnosed according to standard criteria requiring systemic treatment
* Patients must have measurable disease
* Nonsecretory multiple myeloma based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is evaluated Patients must meet clinical laboratory criteria as specified in study protocol
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Female and male patients MUST adhere to the guidelines of the lenalidomide pregnancy prevention program
* Must be able to take concurrent aspirin 325 mg daily
* Voluntary written consent
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
* Peripheral neuropathy that is greater or equal to Grade 2
* Female patients who are lactating or pregnant
* Major surgery or radiotherapy within 14 days before the first dose of study drug
* Serious infection requiring systemic antibiotic therapy within 14 days before the first dose of study drug
* Diarrhea greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events
* Central nervous system involvement.
* Evidence of current uncontrolled cardiovascular conditions within the past 6 months
* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
* Known gastrointestinal condition that could interfere with swallowing or the oral absorption or tolerance of ixazomib
* No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01217957
Study Brief:
Protocol Section:
NCT01217957