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

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;

- 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.

- HTLV 1 or 2 positive;

- Known hypersensitivity to Prevnar or any of its components;

- Contraindication to phosphodiesterase-5 inhibitors (e.g. currently on nitrates).