Clinical trial NCT03389347: High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
Official title: Individualized Treatment for Relapsed/Refractory Multiple Myeloma Based on High Throughput Drug Sensitivity and Genomics Data
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Plasma Cell Leukemia
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple myeloma or plasma cell leukemia with documented relapsed or refractory disease according to International Myeloma Working Group (IMWG) criteria, in any one of the following categories:

  * 3 prior lines of therapy including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI)
  * Less than a very good partial response (VGPR) to initial therapy
  * Early relapse (\< 12 months) after autologous hematopoietic cell transplant (HCT) or after 1st line of therapy
* 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
* 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)

Primary outcomes:
measure: Actionable assay result
timeFrame: Up to 21 days
Secondary outcomes:
measure: Overall response rate to the therapy chosen after performing the assay
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Andrew J. Cowan
role: PRINCIPAL_INVESTIGATOR
References: