Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma
Condition: DS Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Clarithromycin; Dexamethasone; Lenalidomide
Intervention description: Given Orally (PO); Given PO; Given Orally (PO)
Intervention MeSH terms: Clarithromycin; Dexamethasone; Dexamethasone acetate; Lenalidomide; Ichthammol; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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