NCT03389347

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

Individualized Treatment for Relapsed/Refractory Multiple Myeloma Based on High Throughput Drug Sensitivity and Genomics Data

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plasma Cell Leukemia
• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of bone marrow aspirate and blood
DEVICE	High Throughput Screening	Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-02-14
• Primary completion: 2024-12-19
• Completion: 2026-12-19
• First posted: 2018-01-03
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study