drugset / Trial / NCT03634800

Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M)

NCT03634800 ↗

Phase 2 Terminated 6 enrolled Weill Medical College of Cornell University
NaSingle-groupOpen-labelTreatment

Summary

Eligible patients have multiple myeloma with measurable disease in the blood and a targetable soft tissue or bony lesion with radiotherapy. All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy, 6 Gy x 5 fractions, to a targetable lesion. Immunotherapy treatment starts with the first radiotherapy fraction. Nivolumab will be given every 2 weeks. Patients will have specified laboratory values measured bi-monthly and evaluated for response at 12 weeks as defined by International Myeloma Working Group Criteria. Patients will continue to receive their respective immunotherapy until disease progression or dose limiting toxicity is reached.

Timeline

Start
2018-10-23
Primary completion
2020-01-09
Completion
2020-01-16

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of patient accruals.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg Intravenous

Indications