High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
This pilot clinical trial studies whether using high throughput drug sensitivity and genomics
 data is feasible in developing individualized treatment in patients with multiple myeloma or
 plasma cell leukemia that has come back or does not respond to treatment. High throughput
 screen tests many different drugs that kill multiple myeloma cells in individual chambers at
 the same time. Matching a drug or drug combination to a patient using high throughput screen
 and genetic information may improve the ability to help patients by choosing drugs that work
 well for their disease.
PRIMARY OBJECTIVES:

 I. To assess the frequency of obtaining an actionable result from the assay and to estimate
 feasibility as defined as a frequency of at least 50%.

 II. To test patient cells in a high-throughput assay against individual drugs and drug
 combinations within 21 days, to enable optimal choice of drug combinations for therapy.

 SECONDARY OBJECTIVE:

 I. To assess the response rate among patients treated after physicians are presented with the
 testing results.

 OUTLINE:

 Patients undergo collection of bone marrow aspirate and blood for high-throughput drug
 sensitivity assay and mutational analysis using next generation sequencing. Patients and
 their treating physicians receive the results of the tests. Treatment decisions are then made
 by the patients and their treating physicians.

 After completion of study, patients are followed up every 3 months for 2 years.
Inclusion Criteria:

 -  Diagnosis of multiple myeloma with documented relapsed or refractory disease according
 to International Myeloma Working Group (IMWG) criteria, or relapsed/refractory plasma
 cell leukemia

 -  Collection of a bone marrow, fluid or tissue sample that is expected to have enough
 cells to run the assay

 -  Measurable disease defined by one of the following:

 -  Serum monoclonal protein >= 0.5 g/dL by serum protein electrophoresis (SPEP)

 -  >= 200 mg/monoclonal protein in urine on 24 hr urine protein electrophoresis
 (UPEP)

 -  Involved serum free light chain (FLC) >= 10 mg/dL and abnormal
 involved:uninvolved ratio

 -  Plasma cytomas that are palpable per exam or measurable per standard radiologic
 review

 -  Circulating plasma cells >= 2,000 if diagnosis of plasma cell leukemia

 -  Minimum of 3 prior lines of therapy including an immunomodulatory drug (IMiD) and a
 proteasome inhibitor (PI)

 -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

 -  Female patients of child bearing potential and non-vasectomized male patients agree to
 practice appropriate methods of birth control

 -  Ability to understand purpose and risks of the study and provide signed and dated
 informed consent, and authorization to use protected health information

 -  Expected survival is > 100 days

 -  Adequate organ function as determined by the investigator

 Exclusion Criteria:

 -  Mucosal or internal bleeding, or platelet transfusion refractory

 -  Any medical conditions that would impose excessive risk to the patient, or would
 adversely affect his/her participation in the study

 -  Known active infection requiring antibiotics within 7 days of initiation of study
 treatment, unless considered controlled in the opinion of the investigator

 -  Other malignancy with life expectancy < 1 year due to the other malignancy

 -  Pregnant or breast feeding women

 -  Serious psychiatric illness, alcoholism, or drug addiction

 -  Human immunodeficiency virus (HIV), or active hepatitis B or C infection

 -  Previous treatments for multiple myeloma (MM) within 2 weeks of initiation of study
 treatment

 -  Prior autologous or allogeneic stem cell transplantation (SCT) within 12 weeks of
 initiation of study treatment

 -  Prior allogeneic hematopoietic cell transplantation (HCT) with active graft versus
 host disease (GVHD) on therapeutic dosing of immunosuppression or prednisone > 20 mg
 daily equivalent

 -  Prior major surgical procedure or radiation treatment within 2 weeks of initiation of
 study treatment (not including limited radiation used for palliation of bone pain)