Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma

Exclusion Criteria

• •Diagnosis of any of the following cancers:
• •* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes);
• •* Non-secretory myeloma (no measurable protein on Serum Free Lite Assay);
• •* Plasma cell leukemia;
• •Diagnosis of amyloidosis;
• •Failed to achieve at least a partial response (PR) to latest therapy;
• •Previous hematopoietic stem cell transplantation;Patients can have had prior relapsed disease as long as they have never been previously transplanted;
• •Known history of HIV infection;
• •Use of corticosteroids (glucocorticoids) within 21 days of bone marrow collection;
• •Use of any myeloma-specific therapy within 21 days of bone marrow collection;
• •Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration;
• •Participation in any clinical trial within 28 days of registration on this trial, which involved an investigational drug or device;
• •History of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancer;
• •Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is permitted.
• •Human T-lymphotropic virus (HTLV) 1 or 2 positive;
• •Known hypersensitivity to Prevnar or any of its components;
• •Contraindication to phosphodiesterase-5 inhibitors (e.g. currently on nitrates).