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
- 18 years old or greater;
- Patients with active myeloma requiring systemic treatment;
- Newly diagnosed patients. Relapsed myeloma patients that have not previously had a
- 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.
- 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);
- Diagnosis of amyloidosis;
- Previous hematopoietic stem cell transplantation;
- 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 21 days of bone marrow collection
involving 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;
- History of an 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).