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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT02100657
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Prior autologous transplantation (HSCT) patients are allowed.
* Patients must have received at least one previous treatment line of induction, chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib or another proteasome drug
Exclusion Criteria:
* Previous treatment with plitidepsin.
* Active or metastatic primary malignancy other than MM.
* Serious concomitant systemic disorders
* History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or mannitol
* Neuropathy
* Pregnant and/or lactating women
* HIV infection
* Active hepatitis B or C virus infection.
* Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the study
* Plasma cell leukemia at the time of study entry
* Contraindication for the use of steroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02100657
Study Brief:
Protocol Section:
NCT02100657