IRB Number:

07-003064

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have multiple myeloma that has recurred after initial treatment. CC-4047 is a new drug that is related to thalidomide and lenalidomide. The research staff is studying the effects, both good and bad, of CC-4047 in combination with dexamethasone in patients with multiple myeloma that has recurred after initial treatment.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with multiple myeloma that has recurred after initial treatment

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

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:
On their first visit they will have tests done to evaluate their myeloma. These include:
-Blood tests
-24 hour urine sample
-Bone marrow aspirate and biopsy
-Electrocardiogram (a tracing of the electrical activity of the heart)
-Complete set of bone x-rays

Their doctor will ask questions about their medical history and examine the patient. If they are a woman who can have children, they will be required to have a negative pregnancy test 10 to 14 days prior to and again 24 hours before starting therapy. The pregnancy tests must be negative for the patient to start treatment.

If eligible and agreeing to participate, the patient will begin treatment. They will take CC-4047 in capsules at about the same time each day. Every 28 days will be considered one cycle of therapy. The patient will also take dexamethasone, a steroid pill, once a week on days 1, 8, 15 and 22 of each cycle. They will also take aspirin daily, unless the patient can not tolerate aspirin, then an alternative medication may be given. They will be asked to keep a diary to record when they take their medication. The patient will be watched for side effects and the dose will be adjusted if necessary. If their dose is reduced, the schedule of the medication will change to days 1 - 21, followed by seven days of rest for each 28 day cycle.

The patient will need to return to Mayo Clinic every month for a re-evaluation before receiving each cycle of CC-4047, dexamethasone and aspirin. If monthly travel to Mayo Clinic for follow-up is a hardship and they are on a stable dose of CC-4047, after three months of therapy their doctor may allow the patient to reduce the frequency of Mayo follow-up to every three months. If this happens, they will need to see their local doctor monthly and they will need to return to Mayo for a check-up every three months as long as they are receiving the study medication. The patient may only be supplied with one cycle of CC-4047 each 28 days. Bone marrow biopsies may be repeated if their doctor feels it is important for their care.

The drug used in this study (CC-4047) is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use. However the FDA has allowed the use of this drug in this research study.

How long will the Study run?

The patient will be in the study as long as their myeloma is stable or improving. If their myeloma worsens, they will be removed from the study and their health status will
be checked six months later.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 11/09/2007

IRB Review and Approval Date: 09/19/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 37 patients participate from Mayo Clinic.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Martha Q. Lacy, MD

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


• 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
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 11/17/2009