Last updated on March 2019

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


Brief description of study

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 Study 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 OBJECTIVES:

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.

Clinical Study Identifier: NCT03389347

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