High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Plasma Cell Leukemia
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03389347
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Andrew J. Cowan Fred Hutch/University of Washington Cancer Consortium