Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02514382
• Date of registration: 30/07/2015
• Prospective Registration: Yes
• Primary sponsor: University of Southern California
• Public title: Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
• Scientific title: A Phase 1b Study of REOLYSIN® (Reovirus Serotype 3 - Dearing Strain) Combined With Standard Doses of Bortezomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
• Date of first enrolment: August 21, 2015
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02514382
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Kevin Kelly, MD
• Affiliation: University of Southern California

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have relapsed or refractory MM after at least one line of therapy

- Have a confirmed diagnosis of MM with measurable disease, as defined by the presence
of monoclonal immunoglobulin protein in serum electrophoreses of at least 0.5 g/dL for
immunoglobulin G (IgG) or 0.25 g/dL for IgA, or measurable light chain in serum (100
mg/L) or urinary excretion of at least 200 mg monoclonal light chain per 24 hours

- Have NO continuing acute toxic effects (except alopecia) of any prior chemotherapy,
radiotherapy or surgical procedures; all such effects must have resolved to Common
Terminology Criteria for Adverse Events (CTCAE, Version 4.03) grade =< 1; surgery
(except minor procedures such as biopsies, IV line placement, etc.) must have occurred
at least 28 days prior to study enrollment

- Have received NO anti-cancer therapy within 28 days prior to receiving study drug

- Have received NO radiotherapy within 14 days prior to receiving study drug

- Have an Eastern Cooperative Oncology Group (ECOG) Performance score =< 2

- Have a life expectancy of at least 3 months

- Absolute neutrophil count (ANC) >= 1 x 10^9 (International System [SI] units 10^9/L)
(with or without filgrastim [G-CSF])

- Platelets >= 50 x10^9 (SI units 10^9/L)

- Serum creatinine =< 2 x upper limit of normal (ULN)

- Bilirubin =< 1.5 x ULN

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x ULN
if patients have liver involvement with MM)

- Proteinuria < grade 2

- Have a negative pregnancy test if a female with childbearing potential

- Have signed an informed consent indicating that the patient is aware of the neoplastic
nature of their disease and have been informed of the procedures of the protocol, the
experimental nature of the therapy, possible alternative therapies, potential
benefits, side effects, risks, and discomforts

- Be willing and able to comply with scheduled visits, the treatment plan, and
laboratory tests

Exclusion Criteria:

- Have a history of or current evidence of intracranial disease; patients with brain
metastases must be excluded from this clinical trial

- Be on immunosuppressive therapy or have human immunodeficiency virus (HIV) infection
or active hepatitis B or C

- Be a pregnant or breast-feeding woman; female patients of childbearing potential must
agree to use effective contraception, must be surgically sterile, or must be
postmenopausal; male patients must agree to use effective contraception or be
surgically sterile; barrier methods are a recommended form of contraception

- Have clinically significant cardiac disease (New York Heart Association, class III or
IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial
infarction 1 year prior to study entry, or a known history of grade 2 or higher
compromised left ventricular ejection fraction

- Have dementia or altered mental status that would prohibit informed consent

- Have any other severe, acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration or may interfere with the interpretation of study results and, in
the judgment of the principal investigator, would make the patient inappropriate for
this study

- Have a history of allergic (anaphylactic) sensitivity to bortezomib, boron or mannitol

- Have grade 2 or greater neuropathy at the time of screening



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent Plasma Cell Myeloma

Refractory Plasma Cell Myeloma

Intervention(s)

Drug: Bortezomib

Drug: Dexamethasone

Other: Pharmacological Study

Biological: Wild-type Reovirus

Other: Laboratory Biomarker Analysis

Primary Outcome(s)

Incidence of adverse events assessed by CTCAE version 4.03 [Time Frame: Up to 30 days post-treatment]

Secondary Outcome(s)

ORR [Time Frame: Up to 3 years]

Secondary ID(s)

P30CA014089

REO 019

NCI-2015-01069

16M-15-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oncolytics Biotech

National Cancer Institute (NCI)