Phase 1b Study of Myeloma Looking at REOLYSIN in Combination with Bortezomib
Oncolytics Biotech Inc. announced that enrollment has commenced in a Phase Ib study of REOLYSIN combined with standard doses of bortezomib (Velcade) and dexamethasone in patients with relapsed or refractory multiple myeloma. Kevin Kelly, M.D., Ph.D. of the Keck School of Medicine of the University of Southern California (USC), is the principal investigator.
"We recently announced promising early results from another multiple myeloma study examining REOLYSIN in combination with carfilzomib," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our goal is to determine how REOLYSIN performs with the standard of care options in this difficult to treat indication and then take the best combination forward into later-stage testing."
The study is a two-stage open-label Phase Ib trial of adult patients with relapsed or refractory multiple myeloma following at least one line of therapy. The study objectives include determining the maximum tolerated dose ("MTD") and the safety profile of REOLYSIN® in combination with bortezomib and dexamethasone, as well as exploring the toxicities and the pharmacodynamics of the treatment combination, and determining the preliminary response rate in patients with relapsed or refractory multiple myeloma.
Adult patients will receive REOLYSIN on days 1, 2, 8, 9, 15 and 16 of each 28-day cycle. Patients will also receive bortezomib and dexamethasone on days 1, 8 and 15.The first stage of the study will enroll three to six patients in each of two cohorts, with each cohort at a different dose level. The second stage of the study will enroll up to 12 patients at the MTD reached in the first stage.
Trial Information from SparkCures
What is the purpose of this trial?
This phase Ib trial studies the safety and best dose of wild-type reovirus in combination with bortezomib and dexamethasone and to see how well they work in treating patients with multiple myeloma that has returned (relapsed) or does not respond to treatment (refractory). A virus, called wild-type reovirus, may be able to infect cancer cells and slow the cancer growth and kill cancer cells. Bortezomib and dexamethasone may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving wild-type reovirus together with bortezomib and dexamethasone may be a better treatment for multiple myeloma.
Approx. 18 patients
will be enrolled in this study.
Who Sponsors this trial?
- National Cancer Institute (NCI)
- University of Southern California
Trial ID: MM-0748
- 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
- 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 known 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 sensitivity to bortezomib, boron or mannitol
- Have grade 2 or greater neuropathy at the time of screening
- Have progressed while receiving a bortezomib-containing regimen; patients who develop progressive disease as per the International Working Group (IWG) criteria at least 3 months after their last dose of bortezomib are eligible
For study information, please contact Sondra Ortiz, RN at (323) 865-0451 or Sondra.email@example.com.
This trial has 1 active trial site in the US. Find the closest site to your location.