Clinical trial · Interventional
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma
NCT01852591CI-TRIAL-00025763PCV13completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCV 13 | Biological | PCV Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PCV 13
- description
- Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant
- interventionNames
- Biological: PCV 13
Primary outcomes (1)
- measure
- Number of Participants With Immune Response
- timeFrame
- 30 Days Post Vaccine
- description
- Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.
Secondary outcomes (3)
- measure
- CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) \<50 % * Left ventricular ejection fraction (LVEF) \<40% * Bilirubin \>2
References
Publications (0)
Data not yet available
No reference posted for this study.