Clinical trial · Interventional
Viral Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 Study of Reolysin Alone in Patients With Relapsed or Refractory Multiple Myeloma
NCT01533194CI-TRIAL-00017530completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Light Chain Deposition Disease | Light Chain Deposition Disease | ONTOLOGY_EXACT | 0.98 |
| Refractory Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Wild-type Reovirus | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (wild-type reovirus)
- description
- Patients receive wild-type reovirus IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Diagnostic Laboratory Biomarker Analysis
- Biological: Wild-type Reovirus
Primary outcomes (2)
- measure
- Associated adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) criteria and tolerability of wild-type reovirus
- timeFrame
- Up to 4 weeks post-treatment
- description
- The number and severity of toxicity incidents will indicate the level of tolerance for Reolysin in the treatment of relapsed/refractory multiple myeloma. Toxicities will be evaluated using the CTCAE v. 4 standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 drugReferences
Publications (0)
Data not yet available
No reference posted for this study.