Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: aMIL; No aMIL
Intervention description: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.; On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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).