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

Randomized Phase II Study of Autologous Stem Cell Transplantation With Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma

This research is being done to find out if altering the immune system by giving activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.

Inclusion Criteria:

• Age 18 - 80 years old;
• Patients with active myeloma requiring systemic treatment;
• Newly diagnosed patients. Relapsed myeloma patients that have not previously had a transplant;
• Meeting criteria for high-risk disease;
• Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (see Appendix C).
• Meet all institutional requirements for autologous stem cell transplantation;
• The patient must be able to comprehend and have signed the informed consent;
• Patients must have had > than PR after last therapy.

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).