Clinical Trial 17790

Cancer Type: Malignant Hematology
Interventions:Alkeran (Melphalan); CC-5013 (Lenalidomide); Lenalidomide (Revlimid); Marrow Infiltrating Lymphocytes (MILs); Melphalan; Tadalafil

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Frederick Locke

Overview

Study Title

A 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

Summary

The purpose of this study is to find out if altering the immune system by giving Tadalafil, and activated marrow-infiltrating lymphocytes (aMILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.

Objective

Primary: Determine the progression free survival (PFS) of autologous stem cell transplant (ASCT) alone vs ASCT plus MILs. Secondary: Evaluate Toxicity; Evaluate Overall Survival; Determine Immune Responses; Anti-Tumor Immune Responses.

Inclusion Criteria

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  • 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.
  • Meet all institutional requirements for autologous stem cell transplantation.
  • Must be able to comprehend and have signed the informed consent.
  • Must have had > than Partial Response (PR) after last therapy.

  • Exclusion Criteria

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  • 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).