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Lenalidomide and High-Dose Melphalan

2014-08-27 03:15:29 | BioPortfolio

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of Revlimid (lenalidomide) and high-dose Alkeran (melphalan) that can be given to patients with multiple myeloma who will receive an autologous stem cell transplantation. The safety of this combination therapy will also be studied.

Primary objectives:

1. To evaluate the safety of escalating doses of lenalidomide with high dose melphalan in patients with relapsed multiple myeloma

2. To evaluate the efficacy of this combination in terms of CR rates in patients with relapsed multiple myeloma

Secondary objectives:

To evaluate progression-free survival (PFS)

Description

The Study Drugs:

Melphalan is designed to damage the DNA (the genetic material of cells) of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma.

Lenalidomide is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).

- Your complete medical history will be recorded.

- You will have a dental exam to check for any infected teeth or gums that may flare up after chemotherapy.

- You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. This sample will be used to look for changes in your DNA (the genetic material of cells).

- You will have x-rays of your bones taken to check for myeloma-related bone changes.

- You will have a chest x-ray.

- Blood (about 2 tablespoons) and urine will be collected for routine tests. The routine blood draw will include a pregnancy test for women who are able to become pregnant. To take part in this study, the pregnancy test must be negative.

- You will have a pulmonary function test to check your lung function.

- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

- You will also have a echocardiogram to check your heart function.

The study doctor will discuss the screening test results with you. If the screening test show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Dose Levels:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of lenalidomide based on when you join this study. Up to 4 dose levels of lenalidomide will be tested for safety. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen.

All participants will receive the same dose level of melphalan.

Once the highest tolerable dose of the combination of melphalan and lenalidomide is found, the next group of patients will be randomly assigned to 1 of 4 possible groups that will be determined by the computer, based on the safest and most effective dose level at that particular point.

Study Drug Administration:

You will take lenalidomide by mouth 1 time a day beginning 8 days before the stem cell transplant (Day -8). You will take the drug for 7 days (Days -8 through -2). You should take it with a few sips of water.

On Days -3 and -2, you will receive melphalan by vein over 30 minutes.

You will receive standard stem cell transplant care and testing. You will have to sign a separate consent form that describes the transplant procedure and its risks. Your stem cells will be reinfused on Day 0.

Study Visits:

If there is no sign of disease after the transplant, you will have routine follow-up visits:

- Blood (about 2 tablespoons) will be drawn for routine tests at least 1 time a week during Month 1 and then 1 time a month during Months 2-4.

- About 1 month after the transplant, you will have bone marrow biopsies and aspirates performed to check the status of the disease. Blood (about 2 tablespoons) and urine will be collected for routine tests.

- At 1 year after the transplant, you will have x-rays of your bones taken to check the status of the disease.

Length of Study:

One (1) year after the transplant, your participation in this study will be over.

If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have intolerable side effects after you receive melphalan, then you will still have the transplant. However, if intolerable side effects develop before you take melphalan, you may be taken off study without having the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant physician decides it is necessary.

This is an investigational study. Lenalidomide and melphalan are commercially available and FDA approved for the treatment of myeloma. However, the use of lenalidomide with melphalan before an autologous stem cell transplant is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Myeloma

Intervention

Lenalidomide, Melphalan

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

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