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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Actionable Assay Response