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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevnar | Experimental | The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streptococcus pneumoniae | Biological | Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Immune Reconstitution | Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10) | Up to 3 years | |
| Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes |
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DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma OR any of the following high-risk lymphomas:
Diffuse large B-cell lymphoma meeting any of the following criteria:
Follicular lymphoma meeting any of the following criteria:
Hodgkin lymphoma meeting any of the following criteria:
Mantle cell lymphoma meeting any of the following criteria:
T-cell non-Hodgkin lymphoma (NHL) meeting any of the following criteria:
Peripheral T-cell lymphoma, not otherwise specified meeting at least one of the following criteria:
Angioimmunoblastic lymphadenopathy with dysproteinemia
ALK-negative anaplastic NHL
Enteropathy-associated T-cell NHL
Stage III or IV NK-/T-cell NHL at diagnosis
NK-blastic NHL
Has undergone autologous hematopoietic stem cell transplantation and received 200 mg/m² of melphalan (for multiple myeloma) OR BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and methotrexate (for high-risk lymphoma) as conditioning therapy
PATIENT CHARACTERISTICS:
ECOG or WHO performance status 0-2
ANC ≥ 1,000/μL
Platelet count ≥ 75,000/μL
Total bilirubin ≤ 1.5 mg/dL
Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
AST and ALT ≤ 2 times the ULN
Not pregnant or nursing
No severe or uncontrolled systemic illness
No "currently active" second malignancy, other than nonmelanoma skin cancer or carcinoma in situ of the cervix
No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:
No active bacterial, fungal, or viral infection
No known HIV infection or active hepatitis B and/or hepatitis C infection
No other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Craig C. Hofmeister, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevnar | The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| laboratory correlative studies | Other | Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. |
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| quality-of-life assessment | Other | Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance. |
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| Up to 3 years |
| Quality of Life, Including Brief Pain Inventory | The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine. | Up to 3 years |
| Quality of Life, Including Fatigue | Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine. | Up to 3 years |
| Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials | Up to 3 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevnar | The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) laboratory correlative studies: Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing. quality-of-life assessment: Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Immune Reconstitution | Immune reconstitution as measured by response to conjugate vaccine to Streptococcus pneumoniae (Prevnar, PCV7), NK cell activity against autologous lymphoblastoid cell lines, and CMV & EBV tetramer responses after autologous transplant for myeloma | Posted | Count of Participants | Participants | Up to 2 years |
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| |||||||||||||||||||||||||||
| Secondary | Serial Assessment of the Absolute Number of Circulating Regulatory T-cells and the Function of These Cells as Measured by Their Expression of TGFβ and Interleukin-10 (IL-10) | Inadequate material collected to perform these assays | Posted | Up to 3 years |
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| ||||||||||||||||||||||||||||||
| Secondary | Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes | Quality of Life surveys were not completed | Posted | Up to 3 years |
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| ||||||||||||||||||||||||||||||
| Secondary | Quality of Life, Including Brief Pain Inventory | The Brief Pain Inventory - Short Form (BPI-SF) asks respondents to rate the severity of their current, least, average, and worst pain over the previous 24 hours on a scale of 0 to 10. The BPI-SF also asks respondents to rate on a scale of 0 to 10 the degree to which pain interfered with seven different areas of their life (e.g., general activity, normal work, etc.)Scale 0-10 with 0 being no pain and 10 being pain as bad as you can imagine. | Not all patients data was available due to incomplete surveys | Posted | Mean | Standard Deviation | units on a scale | Up to 3 years |
| |||||||||||||||||||||||||||
| Secondary | Quality of Life, Including Fatigue | Brief Fatigue Inventory is a 9-item BFI assessing the severity of fatigue and the impact of fatigue on daily function. Scale 0-10 with 0 being no fatigue and 10 being as bad as you can imagine. | Posted | Mean | Standard Deviation | units on a scale | Up to 3 years |
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| |||||||||||||||||||||||||||
| Secondary | Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials | Data was not collect and analyzed for reporting purposes | Posted | Up to 3 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevnar | The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. Streptococcus pneumoniae: Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT) | 0 | 30 | 0 | 30 | 30 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection with unknown ANC | Infections and infestations | CTCAE version 3.0 | Systematic Assessment | Upper Respiratory Infection |
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| Infection with unknown ANC | Infections and infestations | CTCAE version 3.0 | Systematic Assessment | Pneumo fever with origin unknown |
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| Fever with unknown origin | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Hofmeister, MD | The Ohio State University Comprehensive Cancer Center | 614-293-9869 | Craig.Hofmeister@osumc.edu |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D006689 | Hodgkin Disease |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D007119 | Immunoblastic Lymphadenopathy |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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