Lenalidomide Maintenance Therapy for Multiple Myeloma

Summary

Background: * Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is given to try to extend the response of the first therapy for as long as possible. Research suggests that lenalidomide maintenance therapy may delay the time for myeloma cells to start to grow and possibly improve survival. * Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Researchers want to look at the long-term effect of lenalidomide on immune cells. It will also look at the effects of extended treatment on the cancer and the immune system. Objectives: \- To test the long-term effectiveness of lenalidomide therapy for multiple myeloma. Eligibility: \- Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma. Design: * Participants will be screened with a physical exam and medical history. Blood and urine sample will be collected. A bone scan and bone marrow biopsy will also be performed. * Participants will receive lenalidomide maintenance treatment. It will be given according to the standard of care for multiple myeloma. Participants will take lenalidomide every day for 21 days of repeated 28-day cycles. * Treatment will be monitored with frequent blood tests. Blood tests will look at the effect of the treatment on the immune system. * Treatment will continue as long as the cancer does not worsen and the side effects are not severe.

Timeline

Start

2012-08-20

Primary completion

2016-05-05

Completion

2017-03-10

Outcome

Outcome not reported

Stopped: “Original investigator left the NIH and the primary outcome was not reached”

Publications

• Background Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004 Oct 28;351(18):1860-73. doi: 10.1056/NEJMra041875. No abstract available.
• Background Landgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, Dispenzieri A, Kumar S, Clark RJ, Baris D, Hoover R, Rajkumar SV. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009 May 28;113(22):5412-7. doi: 10.1182/blood-2008-12-194241. Epub 2009 Jan 29.
• Background Rajkumar SV, Kyle RA. Multiple myeloma: diagnosis and treatment. Mayo Clin Proc. 2005 Oct;80(10):1371-82. doi: 10.4065/80.10.1371.

Drugs

Indications