High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    30
  • sponsor
    University of Washington
Updated on 27 April 2021
multiple myeloma
monoclonal antibodies
measurable disease
leukemia
bone marrow procedure
monoclonal antibody therapy
monoclonal protein
serum protein
electrophoresis
plasma cell leukemia
refractory multiple myeloma
immunomodulatory imide drug

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.

Description

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.

Details
Condition Multiple Myeloma, leukemia, Plasma cell leukemia, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Refractory Multiple Myeloma, Leukemia (Pediatric)
Treatment laboratory biomarker analysis, biospecimen collection, High-throughput assay, High Throughput Screening
Clinical Study IdentifierNCT03389347
SponsorUniversity of Washington
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

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)
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