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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT00459069
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
* Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
* 18 years of age or older
* ECOG Performance Status of 0-1 with a greater than nine week life expectancy
* \> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
* Laboratory results within ranges outlined in protocol
* Negative pregnancy test and adequate contraception method(s) must be documented
Exclusion Criteria:
* History of clinically significant venous thromboembolism
* Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
* Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
* Clinically significant autoimmune disease
* HIV positive
* Serious intercurrent illness
* Taking systemic corticosteroids within 4 weeks of treatment with study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00459069
Study Brief:
Protocol Section:
NCT00459069