Lenalidomide Maintenance Therapy for Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01675141

Run by

National Cancer Institute (NCI)

People needed

11

Starts

2012-08-20

Expected to finish

2017-03-10

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with progressive or refractory multiple myeloma (MM), as defined by International Myeloma Workshop Consensus Panel criteria.
• Refractory to lenalidomide in the most recent line of therapy, as defined by the International Myeloma Consensus Panel criteria - as failure to achieve minimal response or development of progressive disease while on lenalidomide or within 30 days of lenalidomide therapy
• Patients who are receiving any other investigational agents with the intent to treat myeloma. Permitted concurrent therapies include:
• Bisphosphonates
• Radiotherapy to single stable disease site
• Plasma cell leukemia
• Pregnant or lactating females. Because there is a potential risk for adverse events to nursing infants secondary to treatment of the mother with lenalidomide, lactating females must agree not to breast feed while taking lenalidomide.
• Uncontrolled hypertension or diabetes
• Active hepatitis B or C infection
• Diagnosed or treated for another malignancy within 3 years prior to study enrollment, with the exception of complete resection of non-melanoma skin cancer, or an in situ malignancy
• Previous diagnosis of another malignancy with any evidence of residual disease.
• Patients seropositive for the human immunodeficiency virus (HIV), and/or those who are taking anti-retroviral treatment for HIV/acquired immune deficiency syndrome (AIDS)
• Prior organ transplant requiring immunosuppressive therapy
• Prior allogeneic stem cell transplant
• Patients requiring continuous, systemic immunosuppressive therapy
• Patients with myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmias, or electrocardiographic evidence of acute ischemia
• Patients with conditions that would prevent absorption of the study drug
• Uncontrolled intercurrent illness including but not limited to uncontrolled infection or psychiatric illness/social situations that would compromise compliance with study requirements
• Significant neuropathy greater than or equal to Grade 3 at baseline
• Contraindication to concomitant anticoagulation prophylaxis
• Major surgery within 1 month prior to enrollment
• Patients who were previously exposed and who developed severe adverse events, hypersensitivity or desquamating rash to either thalidomide or lenalidomide

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.