N/A
Completed N=8
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Source: ClinicalTrials.gov NCT01852591 ↗Enrolled (actual)
8
Serious AEs
42.9%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Immune Response — 5; 5; 5 participants
Summary
There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Immune Response |
5; 5; 5 | — |
| SECONDARY CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) |
0.051; 40.7 | — |
| SECONDARY CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197) |
0.00; 2.69 | — |
| SECONDARY CD8+CD107a+, Best Response Against Vaccine (CRM 197) |
1.19; 8.94 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with confirmed multiple myeloma
- Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
Exclusion Criteria
- Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine
- HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing
- Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
- Active central nervous system (CNS) malignancy
- 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 pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
- Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation
- Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
- Active or uncontrolled infection
- Diffusing lung capacity oxygenation (DLCO) 2
Data sourced from ClinicalTrials.gov (NCT01852591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.