IRB Number:

449-05

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to:

• Test the safety of an antibody (a protein generated by immune system) called rituximab and a radioactive antibody called Yttrium-90 Zevalin when they are given together with standard high-dose melphalan chemotherapy and stem cell transplant


• See what effects (good and bad) this combination therapy has on you and your multiple myeloma


• Learn what effect this treatment has on your blood B lymphocytes after transplant


• See what effects the radioactive antibody (Yttrium-90 Zevalin) has on your myeloma cells.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 who have previously been treated for multiple myeloma and are now a candidate for high-dose therapy with melphalan and stem cell support may be eligible to participate in this research study.

Minimum Age:

18

What is Involved With this Study?

You have already had your stem cells collected, and you are scheduled to have your stem cell transplantation using the standard drug, melphalan. You will get the normal dose of melphalan just as you would if you did not join this study. In this study, rituximab and Zevalin will be added to the melphalan.

On the first day of treatment, you will receive a dose of rituximab by vein followed by a "test dose" of Zevalin labeled with Indium-111. Indium-111 is a small radioactive material that is commonly used to track where antibodies go in the body. The Indium-111 test dose will be done to ensure that the higher treatment dose can be given to you safety and to calculate a dose of Yttrium-90 that will deliver a specific amount of radiation to your body.

After the Indium-111 Zevalin test dose, you will undergo scans over the next week to help your doctors understand where the Zevalin is going in your body. If the results of the scan suggest that the drug does not distribute as expected in your body, you will be taken off of the study. You will be able to go on to your transplant, but will not receive the Yttrium-90 Zevalin. One week after the test dose, you will get another dose of rituximab followed immediately by the calculated dose of Yttrium-90 Zevalin.

Ten days later, you will undergo a bone marrow biopsy and have blood tests to learn the effects of the rituximab and Zevalin on your myeloma. This bone marrow biopsy is being performed for the purposes of this research study and will be used to help learn the effects of the study treatment on your myeloma. You will be offered medicine to make you sleepy during the bone marrow biopsy to minimize the discomfort. During the next two days, you will receive the two doses of melphalan, and then the following day, the stem cells are given back to you by vein. GM-CSF (growth factor) will be given by an injection under the skin starting the day of the stem cell infusion. The GM-CSF injections will continue until your white blood cell count recovers to safe levels.

How long will the Study run?

If the results of the Indium-111 Zevalin "test dose" show that the drug does distribute as expected in your body, you will receive the treatment dose of the 90Y-Zevalin and remain on the study until your myeloma re-appears or gets worse or through 18 months after your transplant.

You will be followed for up to five years after you have started this study so that the researchers can follow your health status. Your health status will be checked either when you return to Mayo for a visit or by sending you or your local doctor a letter.

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: 05/07/2008