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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01045460
Eligibility Criteria:
Inclusion Criteria:
* Durie-Salmon Stage II or III multiple myeloma
* Newly diagnosed either prior to receiving treatment or having completed induction therapy
* Relapsed myeloma not previously transplanted within the past 5 years
* Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable
* Age greater than 18 years old
* ECOG performance status of 0 - 2
* Meet all institutional requirements for autologous stem cell transplantation
* The patient must be able to comprehend and have signed the informed consent
Exclusion Criteria:
* Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes) Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)
* Plasma cell leukemia
* Amyloidosis
* Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection
* Use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine
* In a complete remission at the time of bone marrow collection
* Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection
* Participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device
* History of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer
* Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted
* Evidence of spinal cord compression at time of transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01045460
Study Brief:
Protocol Section:
NCT01045460