Plasma Cell LeukemiaNCT03389347
High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
A study testing Biospecimen Collection, High Throughput Screening and Laboratory Biomarker Analysis in people with Plasma Cell Leukemia and Recurrent Multiple Myeloma, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Leukemia, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Biospecimen Collection, High Throughput Screening and Laboratory Biomarker Analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 24 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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 > 100 days
- Adequate organ function as determined by the investigator
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Individualized Treatment for Relapsed/Refractory Multiple Myeloma Based on High Throughput Drug Sensitivity and Genomics Data
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.
Read the detailed description
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.
- Being tested
- Biospecimen Collection, High Throughput Screening, Laboratory Biomarker Analysis
- Medical subject headings
- Leukemia, Plasma Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of bone marrow aspirate and blood
High Throughput ScreeningDevice
Also called High Throughput Assay
Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (high-throughput assay, sequencing) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Device: High Throughput Screening; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Actionable Assay Response
The feasibility of this approach will be assessed in terms of obtaining an actionable response from the proposed assay in at least 50% of patients examined.
Measured: Up to 21 days
Secondary outcomes (1)
Overall Response Rate to the Therapy Chosen After Performing the Assay
Will be assessed by the International Myeloma Working Group (IMWG) response criteria. The response among all patients who received the assay as well as among patients who obtained an actionable result from the assay will be estimated.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start14 Feb 2018
- Primary completion19 Dec 2024
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plasma Cell LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danai Dima, University of Washington
- Investigators
- Danai Dima, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389347
- Sponsor's protocol ID
- 9944
- Other IDs
- NCI-2017-02204, 9944, RG1017011
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2017
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No