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
High-risk myeloma is associated with a poor clinical outcome despite the development of new drugs over the past decade. This trial attempts to examine whether the addition of T cell immunotherapy within the context of an autologous stem cell transplant can improve clinical outcomes. We have previously shown that T cells obtained from the bone marrow (MILs- marrow infiltrating lymphocytes) of patients with myeloma have a significantly greater anti-tumor effect as compared to T cells from the blood.
This is a randomized trial in which patients with high risk myeloma who are eligible for a stem cell transplant are potentially eligible for this study.
This is a randomized trial in which patients with high risk myeloma who are eligible for a stem cell transplant are potentially eligible for this study. In this study, patients will undergo a bone marrow biopsy to collect the MILs. At that time patients will then be randomized: two-thirds will receive the MILs plus transplant and one-third will undergo a standard transplant. Those randomized to the non-MILs arm of the study will be eligible to receive the MILs upon relapse. Following the transplant, all patients on both arms of the study will be treated for 10 days with tadalafil. Those on the MILs arm will then receive the MILs on day 3 and 4 following the stem cells. All the patients will then also be treated with lenalidomide (Revlimid) maintenance therapy starting at 2-3 months post-transplant. The major endpoint of the study is to determine the time to disease progression.
04/24/2014 04:02 AM