Relapsed/Refractory Multiple Myeloma

Phase II Trial of Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, with Cyclophosphamide, in Patients with Recurrent or Refractory Multiple Myeloma

Principal Investigator:  Dr. van Rhee

Primary Objectives:

Secondary Objectives:

Eligibility:  Relapsed/Refractory


Phase II, Open-label, Study in Subjects with BRAF V600E – Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

Principal Investigator:  Dr. Heuck

Primary Objectives:  To determine the ORR of dabrafenib and trametinib anti-cancer combination therapy in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.

Secondary Objectives:

  • To determine the duration of response of dabrafenib in combination with trametinib in subjects with selected rare BRAF-mutated cancers
  • To determine PFS of dabrafenib in combination with trametinib in subjects with selected rare BRAF-mutated cancers
  • To determine OS of dabrafenib in combination with trametinib in subjects with selected rare BRAF-mutated cancers
  • To determine the safety of dabrafenib in combination with trametinib in subjects with selected rare BRAF-mutated tumors

Eligibility:  Relapsed/Refractory; presence of BRAF V6000E mutation


2010-35 A Phase II Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma

Principal Investigator: Dr. van Rhee

Primary Objective:

To determine the therapeutic efficacy of the exp-NK cell therapy in research participants with relapsed high risk MM [defined as gene expression profile (GEP) 70 gene score ≥0.66 and/or GEP 80 gene score of ≥ 2.48 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L] by establishing the (near) complete response rate. Response rate will be compared to case matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM defined as above). Disease-free survival and overall survival will be captured but are not primary or secondary endpoints.

Secondary Objectives:

To monitor the persistence of exp-NK cells by molecular methods in recipients of haploidentical exp-NK cells;

To determine whether escape from exp-NK cell recognition is the mechanism for relapse in those who fail the proposed therapy

Eligibility:

Patients with high-risk disease; Previously-treated patients; Relapsed/Refractory patients


2011-07 Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients with Relapsed or Refractory B Cell Malignancies

Principal Investigator:  Dr. van Rhee

Primary objective:

To evaluate the safety and tolerability of multiple escalating doses of SNS01-T when administered by intravenous infusion to patients with relapsed or refractory multiple myeloma, MCL, or DLBCL by assessing the frequency, severity, and duration of treatment-related adverse events (AEs) and monitoring changes in vital signs, physical examination, and laboratory values

Secondary objectives: 

To characterize the pharmacokinetic profile of multiple doses of SNS01-T administered intravenously to patients with relapsed or refractory multiple myeloma, MCL or DLBCL by measuring pExp5A plasmid DNA and eIF5A siRNA in blood and bone marrow;

To assess the potential immunogenicity of SNS01-T administered intravenously to patients with relapsed or refractory multiple myeloma, MCL or DLBCL by measuring serum concentrations of antibodies against SNS01-T nanoparticles;

To measure the serum concentrations of select proinflammatory cytokines;

To determine the effect of SNS01-T on time to relapse or progression To determine the effect of SNS01-T on tumor response in multiple myeloma using the International Myeloma Working Group (IMWG) uniform response criteria by analyzing the following:

Changes in serum and urine values of monoclonal protein (M-protein), immunoglobulin (Ig) kappa and lambda free light chain (FLC) and ratio, β2-microglobulin, lactate dehydrogenase, hemoglobin, and C-reactive protein

Changes in bone marrow plasma cell percentage and plasma cell labeling index

To determine the preliminary response of SNS01-T in MCL and DLBCL using the Revised Response Criteria for Malignant Lymphoma, and by assessing changes in appropriate signs, symptoms and lab results