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

Overview

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

SparkCures ID 176
Trial Phase Phase 2
Enrollment 90 Patients
Treatments
Trial Sponsors
  • Sidney Kimmel Comprehensive Cancer Center
Trial Collaborators
  • Leukemia and Lymphoma Society
NCT Identifier

NCT01858558

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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);
  • 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).

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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