Multiple Myeloma Clinical Trial
Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma
Summary
This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma. Biological therapies, such as lenalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone and clarithromycin may be an effective treatment for multiple myeloma.
Full Description
PRIMARY OBJECTIVES:
I. Evaluate the toxicity of the use of lenalidomide/biaxin (clarithromycin)/dexamethasone as maintenance therapy after autologous/syngeneic transplant.
II. Evaluate the median time to disease progression. III. Evaluate survival.
OUTLINE:
Patients receive clarithromycin orally (PO) twice daily (BID) and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO once daily (QD) on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.
After completion of study treatment, patients are followed up periodically.
Eligibility Criteria
Inclusion Criteria:
Any autologous or syngeneic patient who underwent high dose melphalan (>= 140 mg/m^2) therapy/peripheral blood stem cell (PBSC) or bone marrow (BM) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating long-term disease free survival or survival
Platelet count (transfusion independent) > 50,000 cells/mm^3 and absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose therapy
Patients should be between 30 days to 120 days after transplant
Willingness and ability to comply with Food and Drug Administration (FDA)-mandated REV ASSIST Program, Celgene System for Lenalidomide Education and Prescribing Safety
Signing a written informed consent form
Exclusion Criteria:
Karnofsky score less than 70
A left ventricular ejection fraction less than 45% immediately pre transplant; patients with congestive heart disease with transplant, history of myocardial infarction (MI), or history of coronary artery disease
Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease), serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 2.5 x upper limit of normal
Calculated by Cockcroft-Gault formula or measured serum creatinine clearance < 25 ml/minute
Pregnant and/or lactating females
Patients who cannot give informed consent
Patients with untreated systemic infection
Patients with history prior to transplant of treatment with combination therapy Lenalidomide/Biaxin and steroid without response
Patients allergic to lenalidomide, biaxin or dexamethasone
Referring physician not registered with REV ASSIST program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated REV ASSIST Program
Patients unwilling to practice adequate forms of contraception if clinically indicated until 30 days after stopping therapy; male patients on study need to be consulted to use latex condoms (even if they have had a vasectomy) every time they have sex with a woman who is able to have children while they are being treated and for 30 days after stopping drugs
Patients with >= grade 3 peripheral neuropathy
Prior history of uncontrollable side effects to dexamethasone therapy
A prior history of human immunodeficiency virus (HIV) positivity with pre-transplant evaluation
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Seattle Washington, 98109, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.