IRB Number:

06-005263

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Researchers are trying to find new treatments that may be more effective at treating multiple myeloma. The "drug" used in this trial is a modified version of the measles virus used to vaccinate children. The virus has been altered by having an extra gene (piece of DNA) added for a protein called NIS inserted into it. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in a patient's body.

Both the unmodified measles vaccination virus (MV-Edm) and this modified virus (MV-NIS) have been shown to multiply in and destroy myeloma cells in the test tube and in research mice. Researchers hope the MV-NIS will have the same effect in myeloma cells in patients. Because most people have either had the measles or had a measles vaccination, the patient's body may rapidly destroy the MV-NIS. This will be monitored by blood, urine, mouth rinsing, and imaging tests. It is for this reason, however, that some patients may receive in addition to the MV-NIS, a drug called cyclophosphamide. Cyclophosphamide is a common chemotherapy drug which also suppresses the immune system. If researchers find that patients rapidly destroy the MV-NIS, future patients will receive a low dose of cyclophosphamide before the MV-NIS injection to reduce the ability of the patient's immune system to quickly destroy the MV-NIS. Patients will be informed if they will be receiving MV-NIS alone or MV-NIS and the cyclophosphamide.

This virus has not been tested in humans before and it is not a vaccine.

This study is being done to:

-Test the safety of the administration through a vein (IV) of MV-NIS (with or without cyclophosphamide)
-Determine the maximum dose of the virus that can be safely administered in patients with myeloma (with and without cyclophosphamide)
-Determine the fate (where it is, how long it stays there, how it multiplies) of the virus in the body using I-123 with gamma camera imaging. These small doses of radioactive isotope (iodine-123) are used routinely to image the thyroid and other organs without any known problems
-Evaluate the effects of the virus on the body using blood, throat swabs, urine samples and bone marrow biopsies
-Evaluate whether this investigational virus can have any impact on the amount of disease present in patients

Who is Eligible to Participate in the Study?

-Patients age 18 or older diagnosed with recurring or refractory (resistent) multiple myeloma
-Treated with 2 or more prior chemotherapy combinations in the past
-More than 3 weeks since prior chemotherapy
-More than 4 weeks since prior immunotherapy or biologic therapy
-No prior allogenic stem cell transplant

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

This study involves:

-Routine myeloma staging
-Additional research tests both before and after the drugs are given. These tests will be done for safety and to understand where the MV-NIS is going. Patients will not be billed for the research tests.
-Patients will be put in one of 2 groups that will receive either MV-NIS alone or MV-NIS with the drug cyclophosphamide. Patients in both groups will receive different doses of the virus. The study will start with the lowest dose of virus and if no adverse effects are seen in patients treated with the lowest dose, additional patients will be treated with higher dose levels.
-If a patient is in the group of patients scheduled to get cyclophosphamide and MV-NIS, the patient will get 1 dose of cyclophosphamide 2 days before the dose of MV-NIS.
-Medication given through a vein
-Routine blood, urine tests
-Routine bone marrow biopsies
-Routine bone x-rays
-Overnight stay in the General Clinical Research Center
-Outpatient visits

How long will the Study run?

Patients will be in the study for 1 year after receiving the measles virus or until their myeloma gets worse.

Sponsor: Mayo Clinic

IRB Review and Approval Date: November 30, 2006

Study Activation: January 15, 2007

Study Type: Treatment

Projected Accrual: 54 patients

Costs of Study: There may be standard care costs associated with participating in a cancer research study.

Principal Investigator: Dr. Angela Dispenzieri

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 06/10/2008