A Study of Durvalumab (Anti-PDL1) Plus Radiation Therapy for the Treatment of Solitary Bone Plasmacytoma

Conditions

• Solitary Bone Plasmacytoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  durvalumab 1500mg administered intravenously every 28 days, for a total of six doses
• Radiation therapy — RADIATION
  concurrent definitive radiation therapy to the bone plasmacytoma initiated within two weeks of starting

Study Details

This study is being done to evaluate whether the combination of immune therapy and radiation therapy to plasmacytoma that can stimulate the immune system to attack and eliminate the abnormal cells in the bone marrow and perhaps delay or prevent the cancer from worsening. This study will evaluate whether the immune system responds to the combination of radiation with immunotherapy. It is possible that that the combination of immune therapy and radiation may not make any difference in whether or not the patient will develop multiple myeloma in the future.

Key Dates

Start date

Jul 27, 2017

Status verified

Aug 2018

Primary completion

Jun 30, 2020

Completion

Jun 30, 2020

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab Plus Radiation Therapy
  Durvalumab (1500mg administered intravenously every 28 days), concurrently with definitive radiation therapy to the solitary bone plasmacytoma to start within 14 days of the first dose of durvalumab.

Primary Outcome Measure

Response assessment [ Time Frame: up to 36 months from start of cycle 1 ]

Locations (6)

Find similar trials in Basking Ridge, NJ