IRB Number:

07-000710

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Sorafenib and RAD001 are two drugs that block some of the main switch pathways in tumor cells from working properly. When combined, it is hoped that they might prevent the cells from growing or cause them to die. Preliminary experiments with RAD001 in lymphoma patients have shown definite anti-tumor activity.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Relapsed or refractory (resistant) multiple myeloma or biopsy-proven relapsed or refractory non-Hodgkin lymphoma or Hodgkin disease requiring treatment

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

What is Involved With this Study?

This study is divided into 2 phases. The Phase I part will evaluate the best doses of the combination of RAD001 and Sorafenib in patients with multiple myeloma and lymphoma. The Phase II part will further evaluate the dose that is determined to be the best in Phase I and will study how effective the treatment is against lymphoma and multiple myeloma. If agreeing to be in the study, patients will receive up to 12 cycles of treatment. Each cycle is 28 days. Patients will be treated with a combination of both drugs on a daily basis.

After two cycles of treatment the patient's disease will be reevaluated. Patients who have improvement in their disease or stable disease and are tolerating the combination of drugs may receive additional cycles up to a total of 12. After 12 cycles further treatment is up to the physician and the patient and will depend on whether the patient is responding and tolerating the drugs.

Lymphoma Patients procedures and study visits.

Pre-Study
- Routine blood tests and exams
- Bone marrow biopsy and aspirate (part of this will be used for research studies). If the patient has had a bone marrow biopsy and aspirate within the last eight weeks they will not have to have this repeated; but a portion of the biopsy and aspirate collected at that time will be used for the research studies.
- CT scans to document tumor size in patients
- Chest X-ray
- EKG (electrocardiogram)
- Research blood sample
- Pregnancy test (only for women able to become pregnant)

Day 8 and 15 (+/- two days) of first cycle only
- Lymphoma research tissue core needle biopsy [optional for patients who have tissue that is easy to get to] on day 8 or 15
- Research blood sample

Day 1 of each cycle (every four weeks) (+/- one week)
- Routine blood tests and exams
- Chest x-ray (every other cycle unless being used to assess tumor)
- Pregnancy test (only for women able to have children)
- Research blood sample for the first 4 cycles only

Weekly during cycle 1
- Routine blood tests

Day 1 of cycle 3 (+/- one week)
- Routine blood tests and exams
- CT scans to document tumor size
- Research blood sample

Day 1 of cycle 7 (+/- one week)
- Routine blood tests and exams
- CT scans to document tumor size
- Research blood sample

Every three cycles after cycle 6
- Routine blood tests and exams
- CT scans to document tumor size
- Bone marrow biopsy and aspirate for patients who have completely responded to treatment (part of this will be used for research studies)
- Research blood sample

Observation (every three months for the first year)
- Routine blood tests and exams
- CT scans to document tumor size

Observation (every four months for the second year)
- Routine blood tests and exams
- CT scans to document tumor size

Multiple Myeloma Patients procedures and study visits.

Pre-Study
- Routine blood and urine tests and exams
- Bone marrow biopsy and aspirate (part of this will be used for research studies). If patient has had a bone marrow biopsy and aspirate within the last 30 days they will not have to have this repeated; but a portion of the biopsy and aspirate collected at that time will be used for the research studies.
- Chest X-ray
- EKG (electrocardiogram)
- Skeletal survey
- Research blood sample
- Pregnancy test (only for women able to become pregnant)

Day 8 and 15 (+/- two days) of first cycle only
- Research blood sample

Day 1 of each cycle (every four weeks) (+/- four days)
-Routine blood and urine tests and exams
- Chest x-ray (even numbered cycles)
- Pregnancy test (only for women able to become pregnant)
- Research blood sample for the first four cycles only

Weekly during cycles 1-3
-Routine blood tests

After four cycles and 12 cycles
- Routine blood and urine tests and exams
- Skeletal survey (after 12 cycles unless required clinically)
- Chest X-ray
- Bone marrow biopsy and aspirate to document response (part of this will be used for research studies)
- Research blood sample

Observation (every three months for the first year)
- Routine blood and urine tests and exams

Observation (every four months for the second year)
- Routine blood and urine tests and exams

How long will the Study run?

Patients will be in the study for three years.

Sponsor(s): Mayo Clinic Lymphoma SPORE (Specialized Program of Research Excellence)

Study Activation/Registration Date: 08/29/2007

IRB Review and Approval Date: 04/18/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 109 patients participate

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

Principal Investigator: Thomas E. Witzig, 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, 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: 08/28/2008