Viral Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria:

Patient must have relapsed or refractory myeloma that fits or did fit IMWG diagnostic criteria for symptomatic myeloma (although new or worsening end-organ damage is not required to be eligible) as defined below:

Presence of ≥ 10% clonal bone marrow plasma cells
Presence of serum and/or urinary measurable monoclonal protein or light chains

Evidence of any end-organ damage criteria listed below [at any time] attributed to the patient's myeloma:

Hypercalcemia: Serum calcium > 11.5 mg/dL
Renal insufficiency: Serum creatinine > 2 mg/dL
Anemia > 2 g/dL below the lower limit of normal or a hemoglobin value < 10 g/dL
Bone lesions: Lytic lesions, severe osteopenia, or pathologic fractures

Subject must have measurable disease defined as any of the following:

Serum monoclonal protein > 500 mg/dL by protein electrophoresis
> 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
Serum immunoglobulin free light chain ≥ 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Patients must have received at least one prior antineoplastic therapy and must have progressed
No standard therapy is available or patient declines such options
Prior autologous and/or allogeneic transplant is permitted although transplant must have occurred greater than 90 days prior to registration
Adverse events from prior therapy must have recovered to no greater than grade 1 with the exception of grade 2 neuropathy
Prior radiation is permitted; however, at least 4 weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all radiation-associated toxicities to no greater than grade 1 at the time of registration
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%); patients with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible
Life expectancy of greater than 3 months
Absolute neutrophil count (ANC) ≥ 1,000/μL
Platelet count ≥ 50,000/μL
Hemoglobin > 8 g/dL
Total bilirubin < 1.5 mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the institutional upper limit of normal.
Able to understand and willing to sign a written informed consent document
Patients must be able to avoid direct contact with pregnant or nursing women, infants, and immunocompromised individuals during the five days of Reolysin treatment and for two days after
Patients must not have known immunodeficiency virus (HIV) infection or active hepatitis B or C infections
For patients with a history of congestive heart failure, systolic cardiac function must be assessed at screening and left ventricular ejection fraction (LVEF) ≥ 50%
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to starting therapy and prior to beginning another course (if applicable)
FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

The patient must be willing to comply with fertility requirements as below:

Male patients must agree to use an adequate method of contraception for the duration of the study and for 90 days afterwards
Female patients must be either postmenopausal, free from menses ≥ 2 years, surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening and for 90 days afterwards
Patients must agree not to donate blood or sperm/ova during the course of taking protocol therapy and for at least 4 weeks after stopping treatment

No patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study

Patients may be receiving concomitant therapy with bisphosphonates and low-dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment
No patients who are receiving any other investigational agents
No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study
No patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation
No POEMS syndrome
No concurrent use of complementary or alternative medicines that, in the opinion of the principal investigator, would confound the interpretation of toxicities and/or antitumor activity of the study drug