Clinical Trial: Lenalidomide for Patients With Myelofibrosis (MF)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)

Brief Summary: The goal of this clinical research study is to learn if lenalidomide in combination with prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied.

Detailed Summary:

Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Prednisone is designed to improve the results of lenalidomide and to help reduce the side effects.

If you are found to be eligible to take part in this study, you will take 1-2 capsules of lenalidomide by mouth daily. You will take lenalidomide daily for 21 days followed by 1 week rest. This 28-day period is called a study "cycle."

Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules.

If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).

You will take prednisone by mouth every day during Cycles 1-2, and every other day during Cycle 3. You may only take prednisone for Cycles 1-3.

You will be given a study drug diary. In this diary, you will record when you take the study drug(s).

During treatment, blood (about 1 tablespoon) will be drawn once every 1-2 weeks. Following the completion of 24 cycles, blood (about 1 tablespoon) will be drawn every 1- 3 months. The tests may be repeated more frequently to check for side effects.

Every month for the first 3 months, and then every 3 months, until you complete 24 cycles, you will have a study visit. You will have a bone marrow biopsy/aspirate
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Number of Patients with Objective Response (Complete and Partial Response + Hematological Improvement) [ Time Frame: Baseline and with each 28 Day Cycle ]

Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death.


Original Primary Outcome: To determine the efficacy of lenalidomide and prednisone in combination in patients with MF, in achieving objective improvements in disease status: complete and partial response, and hematologic improvement.

Current Secondary Outcome:

Original Secondary Outcome: - To determine the safety of lenalidomide and prednisone in combination, in patients with MF and to examine pertinent morphological, biological, and molecular characteristics of MF in patient samples during therapy with lenalidomide and prednisone.

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: July 14, 2006
Date Started: July 2006
Date Completion: July 2019
Last Updated: May 11, 2017
Last Verified: May 2017