High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Pati… (NCT03389347) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
United States40 participantsStarted 2018-02-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of multiple myeloma or plasma cell leukemia with documented relapsed or refractory disease according to International Myeloma Working Group (IMWG) criteria, in any one of the following categories:
* 3 prior lines of therapy including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI)
* Less than a very good partial response (VGPR) to initial therapy
* Early relapse (\< 12 months) after autologous hematopoietic cell transplant (HCT) or after 1st line of therapy
* 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
* 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 …
What they're measuring
1
Number of Participants With Actionable Assay Response