A Phase 1 Study of Reolysin Alone in Patients With Relapsed or Refractory Multiple Myeloma
I. Determine safety and tolerability of Reolysin in patients with relapsed multiple myeloma.
II. Obtain evidence of Reovirus replication by immunohistochemical co-localization of
Reovirus and tubulin staining in marrow clot sections obtained on cycle 1 day 8.
I. Obtain preliminary data on response as determined by International Myeloma Working Group
criteria after infusion of Reolysin as a single agent. (Clinical) II. Obtain pilot overall
and progression free survival data for all treated patients. (Clinical) III. Assess
neutralizing anti-reovirus assay (NARA) results on days 1, 8, 15, and once days 22-28 during
cycle 1. (Correlative) IV. Assess feasibility of staining for RAF/MEK/ERK in CD138+ cells
using marrow clot sections obtained from pre-treatment specimen. (Correlative) V.
Cryopreserve PBMCs for future ancillary studies focused initially on lymphocyte subset(s)
and myeloid derived suppressor cell changes after Reolysin infusion during cycle 1.
(Correlative) VI. Cryopreserve CD138+-selected cells at screening and after treatment for
future ancillary studies of genetic and epigenetic changes focused in part on endoplasmic
reticulum (ER) stress. (Correlative)
OUTLINE: This is a dose-escalation study.
Patients receive wild-type reovirus IV over 60 minutes on days 1-5. Treatment repeats every
28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow aspirate at baseline and periodically during study for
RAF/MEK/ERK expression and wild-type reovirus replication analysis by immunohistochemistry.
Blood and cryopreserved CD138+ selected cell samples are also collected for future ancillary
After completion of study treatment, patients are followed up for 4 weeks.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Associated adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) criteria and tolerability of wild-type reovirus
The number and severity of toxicity incidents will indicate the level of tolerance for Reolysin in the treatment of relapsed/refractory multiple myeloma. Toxicities will be evaluated using the CTCAE v. 4 standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
Up to 4 weeks post-treatment
Ohio State University Comprehensive Cancer Center
United States: Food and Drug Administration
|The Ohio State University Medical Center||Columbus, Ohio 43210|