Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had previous treatments for multiple myeloma within 2 weeks of starting the study treatment.
What data supports the idea that Individualized Treatment Plans for Multiple Myeloma is an effective treatment?
The available research shows that Individualized Treatment Plans for Multiple Myeloma, like the Ex vivo Mathematical Myeloma Advisor (EMMA), can accurately predict how patients will respond to different drugs. In a study with 52 patients, EMMA correctly identified 96% of responders and non-responders. Another study used a 7-gene signature to predict which patients would benefit most from specific drug combinations, leading to better survival outcomes. These personalized approaches help choose the most effective treatments, improving patient outcomes compared to standard treatments.12345
What safety data exists for individualized treatment plans for multiple myeloma?
The safety data for individualized treatment plans for multiple myeloma includes information from various studies and reports. The FDA's boxed warnings impact adverse drug reactions reporting rates for multiple myeloma drugs, highlighting the importance of monitoring these reactions. Novel agents have specific side effect profiles, and guidelines exist for managing these adverse events. Post-marketing safety data from the FDA's Adverse Event Reporting System shows that immunomodulatory drugs (IMiDs) like thalidomide, lenalidomide, and pomalidomide have significant adverse event signals, including cardiac, gastrointestinal, and respiratory disorders. Real-world data indicates that treatment decisions should consider efficacy, safety, tolerability, and quality of life, as many patients do not meet clinical trial criteria. Patient-reported outcomes and physician-patient concordance on side effects are also important for understanding treatment impact.678910
Is High Throughput Screening a promising treatment for multiple myeloma?
Yes, High Throughput Screening is a promising treatment for multiple myeloma because it helps doctors predict how well a patient will respond to different drugs, allowing for personalized treatment plans. This approach can lead to better treatment outcomes by identifying the most effective drugs for each individual patient.1351112
Research Team
Andrew Cowan, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for adults with relapsed or refractory multiple myeloma or plasma cell leukemia who have tried at least three prior treatments, including an IMiD and a PI. They must be able to consent, practice birth control if applicable, have adequate organ function, and measurable disease. Excluded are those with HIV/hepatitis B/C, recent major treatments like SCT within 12 weeks, active infections requiring antibiotics within 7 days of study start.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- High Throughput Screening (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor