Viral Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT01533194 | Completed Phase 1

• 7 other identifiers: NCI-2012-00248CDR00007248572011C01419030OSU 11148P30CA016058U01CA076576
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Light Chain Deposition Disease; Refractory Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• Associated adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) criteria and tolerability of wild-type reovirus

  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.

  Up to 4 weeks post-treatment

• Maximum-tolerated dose level

  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.

  28 days

Secondary Outcomes (4)

• Duration of response

  Up to 2 years

• Objective response rate

  Up to 4 weeks post-treatment

• Progression-free survival

  From start of treatment to disease progression or death, regardless of cause of death, whichever comes first, assessed up to 2 years

• Time to progression

  Time from the start of the treatment until the criteria for disease progression are met, assessed up to 2 years

Study Arms (1)

Treatment (wild-type reovirus)

EXPERIMENTAL

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.

Other: Diagnostic Laboratory Biomarker Analysis; Biological: Wild-type Reovirus

Interventions

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (wild-type reovirus)

Wild-type Reovirus BIOLOGICAL

Given IV

Also known as: Reolysin

Treatment (wild-type reovirus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

reolysin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Craig Hofmeister

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2012
• First Posted: February 15, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 15, 2015

Record last verified: 2014-12

Locations

US (1)