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

  • End date
    Jun 1, 2024
  • participants needed
  • sponsor
    University of Washington
Updated on 27 April 2021
multiple myeloma
monoclonal antibodies
measurable disease
bone marrow procedure
monoclonal antibody therapy
monoclonal protein
serum protein
plasma cell leukemia
refractory multiple myeloma
immunomodulatory imide drug


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.



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.


I. To assess the response rate among patients treated after physicians are presented with the testing results.


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.

Condition Multiple Myeloma, leukemia, Plasma cell leukemia, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Refractory Multiple Myeloma, Leukemia (Pediatric)
Treatment laboratory biomarker analysis, biospecimen collection, High-throughput assay, High Throughput Screening
Clinical Study IdentifierNCT03389347
SponsorUniversity of Washington
Last Modified on27 April 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of multiple myeloma with documented relapsed or refractory disease according to International Myeloma Working Group (IMWG) criteria, or relapsed/refractory plasma cell leukemia
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
Minimum of 3 prior lines of therapy including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI)
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 > 100 days
Adequate organ function as determined by the investigator

Exclusion Criteria

Mucosal or internal bleeding, or platelet transfusion refractory
Any medical conditions that would impose excessive risk to the patient, or would adversely affect his/her participation in the study
Known active infection requiring antibiotics within 7 days of initiation of study treatment, unless considered controlled in the opinion of the investigator
Other malignancy with life expectancy < 1 year due to the other malignancy
Pregnant or breast feeding women
Serious psychiatric illness, alcoholism, or drug addiction
Human immunodeficiency virus (HIV), or active hepatitis B or C infection
Previous treatments for multiple myeloma (MM) within 2 weeks of initiation of study treatment
Prior autologous or allogeneic stem cell transplantation (SCT) within 12 weeks of initiation of study treatment
Prior allogeneic hematopoietic cell transplantation (HCT) with active graft versus host disease (GVHD) on therapeutic dosing of immunosuppression or prednisone > 20 mg daily equivalent
Prior major surgical procedure or radiation treatment within 2 weeks of initiation of study treatment (not including limited radiation used for palliation of bone pain)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note