Participant flow

Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M) · Source last updated 2021-08-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion. * 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 * 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 Nivolumab 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. Radiation 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

   FG000

   title

   Nivolumab/Radiotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Patients were screened and enrolled at 1 site in the US: Weill Cornell Medicine (NY, NY).

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice