{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment.\n\nPatients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. Prevnar vaccine will be administered with the GM-CSF vaccine administration.\n\nGM-CSF vaccine: Each vaccination will consist of three total intra-dermal injections, on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). In the event that the specified limb is contraindicated, the dominant arm may be used. Vaccine injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each vaccination injection is approximately 0.7-0.8ml.\n\nLenalidomide: 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).\n\nPrevnar13: Prevnar will be administered at the same time points as the GM-CSF vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Lenalidomide Plus GM-CSF Vaccine Plus Prevnar13 (Arm A)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients will also get placebo GM-CSF vaccine and placebo prevnar13. Placebo will be saline.\n\nLenalidomide: 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).\n\nPlacebo Prevnar13: Saline will be used for placebo. Placebo prevnar will be administered at the same time points as the GM-CSF vaccine or Placebo GM-CSF Vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine or placebo GM-CSF vaccine.\n\nPlacebo GM-CSF Vaccine: Saline will be used for placebo. Each placebo vaccine will consist of three total intra-dermal injections on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). In the event that the specified limb is contraindicated, the dominant arm may be used. Placebo injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each injection is approximately 0.7-0.8ml.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Lenalidomide Only (Arm C)"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment.\n\nPatients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. Patients will also be administered a placebo prevnar13 vaccination. Placebo will be saline.\n\nGM-CSF vaccine: Each vaccination will consist of three total intra-dermal injections, on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). In the event that the specified limb is contraindicated, the dominant arm may be used. Vaccine injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each vaccination injection is approximately 0.7-0.8ml.\n\nLenalidomide: 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).\n\nPlacebo Prevnar13: Saline will be used for placebo. Placebo prevnar will be administered at the same time points as the GM-CSF vaccine or Placebo GM-CSF Vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine or placebo GM-CSF vaccine.","id":"EG002","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Lenalidomide Plus GM-CSF Vaccine (Arm B)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":1,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE v5","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Basal cell, nose"}],"timeFrame":"From enrollment up to 2 years"}