Viral Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT01533194) | Clinical Trial Compass
CompletedPhase 1
Viral Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
United States12 participantsStarted 2012-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Associated adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) criteria and tolerability of wild-type reovirus