Viral Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Light Chain Deposition Disease, Refractory Plasma Cell Myeloma

In brief

This pilot phase I trial studies the side effects and the best dose of giving viral therapy to patients with relapsed or refractory multiple myeloma. Viral therapy, such as wild-type reovirus, may be able to kill cancer cells without damaging normal cells.

Key facts

Study ID

NCT01533194

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2012-04-01

Expected to finish

2015-02-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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