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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00044463 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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This research is being done to find out if the investigators can improve outcomes for multiple myeloma patients by giving a myeloma vaccine to patients who are already on lenalidomide (Revlimid) and in a near complete remission.
This is a single institution, single arm, Phase II study examining the clinical efficacy of an allogeneic GM-CSF secreting myeloma vaccine in combination with lenalidomide. Fifteen (15) patients enrolled in the study must have two disease measurements (including the last one) consistent with a near complete remission (M-spike negative with persistence of immunofixation) per criteria for response in a 6 month period. Patients will continue on the dose of lenalidomide they were on prior to being enrolled but will need to discontinue steroids for at least 4 weeks. Patients will receive 4 vaccinations on day 14(+/-3 days) of cycles 1, 2, 3 and 6 from enrollment that will include both the myeloma vaccine as well as Prevnar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myeloma Vaccine, Prevnar, & Lenalidomide | Experimental | Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Response Conversion Rate | Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Median time for conversion of response from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells. as measured by immunofixation converting from positive to negative. |
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Inclusion Criteria:
Myeloma eligibility criteria are the following:
age 18 years and older
Eastern Cooperative Oncology Group performance scores 0-2
History of measurable serum or urine M protein or free light chains
Life expectancy greater than 12 months
Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia
Serum creatinine< 2
Absolute Neutrophil Count >1000
Platelet >100,000
Total bilirubin less than or equal to 1.5 x Upper limit of normal
Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper limit of normal
Negative pregnancy test if applicable
Ability to comprehend and have signed the informed consent.
Disease free of prior malignancies for < 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Borrello, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
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Two participants were screen failures. One participant withdrew consent prior to starting the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide | Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant withdrew consent prior to receiving the study intervention, leaving sixteen participants who received at least one day of intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide | Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13: Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Response Conversion Rate | Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells. | Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. | Posted | Count of Participants | Participants | Up to 1 year |
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Up to 1 year
Adverse events were assessed every 28 days.
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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 | Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide | Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle). Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ivan Borrello, MD | Johns Hopkins University | 4109554967 | iborrell@jhmi.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
|
| Allogeneic Myeloma Vaccine | Biological | A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed. |
|
| Prevnar-13 | Biological | Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine. |
|
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| Up to 4 years |
| Effect on Clonogenic Myeloma Precursors | Measures of stem cell population and plasma cell population. | Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year |
| Grade 3-4 Toxicity | Number of participants who experienced grade 3-4 toxicity as per CTCAE 4.0. | Up to 1 year |
| Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells | Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers. | Baseline, Cycle 3 Day 14, end of study (up to 1 year) |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
| Secondary | Time to Response | Median time for conversion of response from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells. as measured by immunofixation converting from positive to negative. | Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. | Posted | Median | Full Range | months | Up to 4 years |
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|
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| Secondary | Effect on Clonogenic Myeloma Precursors | Measures of stem cell population and plasma cell population. | Data was not collected for this outcome measure due to technical difficulties in the assay. | Posted | Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year |
|
|
| Secondary | Grade 3-4 Toxicity | Number of participants who experienced grade 3-4 toxicity as per CTCAE 4.0. | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Secondary | Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells | Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers. | Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. Only 8/15 participants experienced complete response (CR), therefore only 8 participants analyzed in the CR rows and 7 participants analyzed in the progressive disease (PD) rows. | Posted | Mean | Standard Deviation | percentage of cells | Baseline, Cycle 3 Day 14, end of study (up to 1 year) |
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| 0 |
| 16 |
| 1 |
| 16 |
| 15 |
| 16 |
| Chest congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest pressure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain - chest wall | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral edema | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Injection site reactions | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Interface haze | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Lump - left wrist | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Cramping | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain - knee | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain - mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain - right side | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain - abdomen | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| CR patients at Cycle 3 Day 14 |
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| CR patients at end of Study |
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| Progressive Disease (PD) patients at Baseline |
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| PD patients at Cycle 3 Day 14 |
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| PD patients at end of study |
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