Vaccine Therapy in Treating Patients Who Have Undergone Autologous Stem Cell Transplant for High-Risk Lymphoma or Multiple Myeloma
| Tracking Information | |||||
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| First Received Date ICMJE | December 6, 2007 | ||||
| Last Updated Date | June 10, 2012 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Immune reconstitution [ Time Frame: 2007-present ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Immune reconstitution | ||||
| Change History | Complete list of historical versions of study NCT00569309 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy in Treating Patients Who Have Undergone Autologous Stem Cell Transplant for High-Risk Lymphoma or Multiple Myeloma | ||||
| Official Title ICMJE | Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma | ||||
| Brief Summary | RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy after an autologous stem cell transplant may kill any cancer cells that remain after transplant. PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients who have undergone autologous stem cell transplant for high-risk lymphoma or multiple myeloma. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients receive pneumococcal polyvalent vaccine intramuscularly once in weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation. Blood samples are collected periodically for correlative and immunological studies. Quality of life (QOL) is assessed periodically using the QOL short form (SF-36, 4-week version), the Center for Epidemiologic Studies Depression scale (CES-D), and the Multidimensional Fatigue Symptom Inventory (MFSI-30). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00569309 | ||||
| Other Study ID Numbers ICMJE | OSU-07044 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Craig Hofmeister, Ohio State University Comprehensive Cancer Center | ||||
| Study Sponsor ICMJE | Craig Hofmeister | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University Comprehensive Cancer Center | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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