{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}],"title":"CR (complete response)"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"VGPR (Very Good Partial Response)"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"PR (Partial Response)"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"No change/Stable disease"},{"measurements":[{"groupId":"OG000","value":"2"}],"title":"PD (Progressive disease)"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"Relapse"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"description":"The primary aim is to estimate the overall response at 12 weeks using IMWG criteria. Per IMWG response criteria, Complete Response (CR) is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow; Very Good Partial Response (VGPR) is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \\> 90% reduction in serum M-protein plus urine M-protein level \\< 100 mg/24 h; Partial Response (PR) is defined as \\> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \\>90% or to \\< 200 mg/24 h, No change/Stable disease is defined as not meeting criteria for CR, VGPR, PR, or progressive disease; Progressive disease (PD) is defined as an increase of \\> 25% from lowest response value; Relapse is define as development of new soft tissue plasmacytomas or Definite increase in the size of existing plasmacytomas or bone lesions.","groups":[{"description":"All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion.\n\n* Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached\n* Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab\n\nNivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.\n\nRadiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.","id":"OG000","title":"Nivolumab/Radiotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Out of the 5 patients that started treatment, only 3 patient made it to 12 weeks of treatment.","reportingStatus":"POSTED","timeFrame":"12 weeks","title":"To Determine Overall Response at 12 Weeks Using International Myeloma Working Group (IMWG) Criteria in Patients Will be Measured","type":"PRIMARY","unitOfMeasure":"Participants"}