Clinical Trials

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.
• 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).