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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00024466
Eligibility Criteria:
INCLUSION CRITERIA
Initial Presentation
* Age between 18 and 70 years
* ECOG 0 - 2
* Patients with histologically confirmed multiple myeloma with ≥ 30% bone
* marrow involvement and a de novo presentation. One cycle of prior
* chemotherapy for myeloma is allowed. Local radiation therapy is permitted
* Ability to give informed consent
* No existing secondary malignancies and no history of secondary malignancies in the past 5 years (other than a history of carcinoma in situ of the cervix, superficial skin cancer, or superficial bladder cancer)
* No active autoimmune disease, nor a history of any autoimmune disease requiring medical treatment with systemic immunosuppressants
* No corticosteroids within 28 days of tumor harvest
* No major active medical or psychosocial problems that could be exacerbated or complicated by this treatment
* Not pregnant
* HIV negative
* AST/ALT, total bilirubin \< threefold normal
* Absolute neutrophil count \>500/mm3
* Platelet count \>30,000/mm3
Prior to Transplantation
* ECOG performance status of 0 - 2.
* No active/uncontrolled infection.
* Absolute neutrophil count (ANC) \>1000/mm3.
* Platelet count \>50,000/mm3.
* Hemoglobin \>8g/dL
* AST/ALT, total bilirubin \<3-fold normal.
* 50% or greater reduction in tumor burden with prior chemotherapy
* Patient has received a minimum of 2 cycles of an accepted induction
* chemotherapy regimen
* Patient fulfills the requirements for standard peripheral stem cell transplantation Prior to Posttransplant Vaccination
* No active/uncontrolled infection
* Absolute neutrophil count (ANC) \>1000/mm3
* Platelet count \>50,000/mm3
* Hemoglobin \>8g/dL
* AST/ALT, total bilirubin \<3-fold normal
* No unresolved Grade 3 or 4 adverse events related to the transplant
EXCLUSION CRITERIA
• Failure of autologous tumor-cell processing for vaccine production
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00024466
Study Brief:
Protocol Section:
NCT00024466