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Protocol No. 2015LS057 Principal Investigator Bachanova, Veronika
Phase Phase I
Age Group Adult Scope Local
Title MT2015-46 : A Phase I Trial Testing NAM Expanded Haploidentical or Mismatched Related Donor Natural Killer (NK) Cells Followed by a Short Course of IL-2 for the Treatment of Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory CD20+ Non-Hodgkin Lymphoma
Objective Primary Objective: To determine the dose of HLA-haploidentical or HLA-mismatched related donor, nicotinamide expanded-natural killer (NAM-NK) cells that is most closely associated with a low rate of any grade 4 or greater suspected adverse reaction within 24 hours after the NAM-NK cell infusion or Grade III or IV acute graft-versus-host disease (aGVHD) within 28 days after the NAM-NK cell infusion when given after lymphodepleting chemotherapy and followed by a short course of IL-2 in adults with relapsed/refractory MM or relapsed/refractory CD20-positive NHL. Secondary Objectives: To evaluate the safety of the therapy as measured by rate of treatment related mortality (TRM) at 2 months To obtain a preliminary estimate of efficacy as measured by monitoring the rates of disease response at day 28 To evaluate duration of response for up to 1 year post NAM-NK cell infusion
Description This is a single center phase I trial with pilot expansion of HLA-haploidentical or HLAmismatched related donor nicotinamide expanded-natural killer (NAM-NK) cell based therapy for patients with relapsed or refractory multiple myeloma (MM) or relapsed/refractory CD20-positive non-Hodgkin lymphoma (NHL).
Key Eligibility Relapsed or Refractory Multiple Myeloma or CD20+ B cell Non-Hodgkin lymphoma (NHL) between the ages of 18 and 70 years of age
Applicable Disease Sites Multiple Myeloma
Non-Hodgkin's Lymphoma
Therapies Involved Chemotherapy
Immunotherapy
Drugs Involved CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
Elotuzumab
FLUDARABINE (FLUDARA)
IL-2 (INTERLEUKIN-2, ALDESLEUKIN,PROLEUKIN)
RITUXIMAB (RITUXAN)
Status Open
Participating Institutions Masonic Cancer Center
Treatment Type Treatment
Contact Veronika Bachanova Phone:612-625-5469
Email:bach0173@umn.edu