Previously Treated 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


2008-03 Total Therapy 6: Phase II Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy (No Prior Transplant)

Principal Investigator: Dr. Morgan

Primary Objective:

To determine the rate of complete and near-complete response at two years after initiation of therapy

Secondary objectives:

To determine the frequency and duration of continued complete and near-complete response in relationship to: Duration of prior therapy (<6 months versus 6-12 months);.Prior response; Type of initial therapy, such as regimens containing Velcade or immunomodulatory agents (thalidomide, Revlimid) with or without melphalan

To determine duration of complete response and near-complete response

To determine event-free survival and overall survival

Translational research:

To apply separately bortezomib and low-dose Melphalan 10 mg/m2 and examine, via serial gene expression profiling (GEP) examinations of CD138-purified MM plasma cells (PC) and of un-separated bone marrow biopsy (BX) samples, whether “response” and “resistance” GEP signatures can be identified via short-term GEP alterations in PC and BX, analogous to observations in TT3 with Velcade

A sub-aim examines whether melphalan-induced changes are tumor cell specific or might be genetically predetermined; toward this aim, we will compare and contrast GEP in peripheral blood mononuclear cells and myeloma tumor cells prior to and following drug dosing


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