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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02851056
Eligibility Criteria:
Inclusion Criteria:
Screening:
* As of protocol Version 2 there is no "screening phase".Patients previously consented to the screening phase could still be eligible for treatment if consented for treatment, based upon the updated eligibility criteria.
Treatment:
* Patients with histologically confirmed Multiple Myeloma that are being considered for high dose chemotherapy and autologous stem cell transplant.
* Patients must have a bone marrow biopsy available, or one scheduled to be performed for a clinical indication so that survivin expression could be determined (note: survivin staining in tumor need not be resulted prior to enrollment or treatment as it is obtained for correlative science).
* Patients planned for treatment with high dose melphalan and autologous hematopoietic cell transplant (HCT).
* Complete blood count (CBC) with an absolute neutrophil count (ANC) \>= 1,000/uL, hemoglobin \>= 8.0 g/dL and platelet count \>= 50,000/uL.
* Liver enzymes: total bilirubin less than or equal to 2 mg/dL (\>2 mg/dL permitted if the patient has evidence of Gilbert's disease based upon prior bilirubin elevation or genetic testing); Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 1.5 X the upper limit of normal (ULN).
* Signed informed consent form in accordance with institutional and federal law policies.
Exclusion Criteria:
Treatment:
* Patients with Complete Response (CR) or stringent CR after induction therapy as defined by International Response Criteria after most recent therapy.
* Patients with progressive disease at time of transplant.
* Pregnant or lactating woman (as evaluated by serum testing within 48 hours of administration of the first vaccine in women of child bearing potential).
* HIV infection confirmed by nucleic acid tests (NAT).
* Common variable immunodeficiency.
* Active central nervous system (CNS) malignancy.
* Active bacterial, fungal or viral infection.
* Prior history of allogeneic hematopoietic cell transplantation
* Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy.
* History of severe allergy (e.g., anaphylaxis) to any component of Prevnar or any diphtheria-toxoid containing vaccine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02851056
Study Brief:
Protocol Section:
NCT02851056