Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02101944
Phase
PHASE1
Status
Completed

Conditions

  • Anemia
  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carfilzomib — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pelareorep — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of wild-type reovirus when combined with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back following treatment (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as dexamethasone and carfilzomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. A virus called wild-type reovirus may be able to kill cancer cells without damaging normal cells and seems to work best when given with chemotherapy. Giving wild-type reovirus with chemotherapy may be a more effective treatment than chemotherapy alone.

Key Dates

Start date
Dec 9, 2014
Status verified
May 2024
Primary completion
May 5, 2021
Completion
May 7, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (dexamethasone, carfilzomib, Reolysin)
    Patients receive dexamethasone intravenously (IV), carfilzomib IV over 30 minutes, and Reolysin IV over 60 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number and severity of adverse events [ Time Frame: Up to 4 weeks post treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GAOhio State University Comprehensive Cancer Center· Columbus, OHHuntsman Cancer Institute/University of Utah· Salt Lake City, UT

Related Studies