High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
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ClinicalTrials.gov Identifier: NCT03389347 |
Recruitment Status :
Recruiting
First Posted : January 3, 2018
Last Update Posted : April 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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Plasma Cell Leukemia Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma | Procedure: Biospecimen Collection Device: High Throughput Screening Other: Laboratory Biomarker Analysis | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Individualized Treatment for Relapsed/Refractory Multiple Myeloma Based on High Throughput Drug Sensitivity and Genomics Data |
Actual Study Start Date : | February 14, 2018 |
Estimated Primary Completion Date : | June 1, 2023 |
Estimated Study Completion Date : | June 1, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Device feasibility (high-throughput assay, sequencing)
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.
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Procedure: Biospecimen Collection
Undergo collection of bone marrow aspirate and blood Device: High Throughput Screening Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay
Other Name: High Throughput Assay Other: Laboratory Biomarker Analysis Correlative studies |
- Actionable assay result [ Time Frame: Up to 21 days ]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.
- Overall response rate to the therapy chosen after performing the assay [ Time Frame: Up to 2 years ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389347
Contact: Andrew J. Cowan | 206-606-7348 | ajcowan@seattlecca.org |
United States, Washington | |
Fred Hutch/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Andrew J. Cowan 206-606-7348 ajcowan@seattlecca.org | |
Principal Investigator: Andrew J. Cowan |
Principal Investigator: | Andrew J. Cowan | Fred Hutch/University of Washington Cancer Consortium |
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT03389347 |
Other Study ID Numbers: |
9944 NCI-2017-02204 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 9944 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) RG1017011 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) |
First Posted: | January 3, 2018 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Leukemia Multiple Myeloma Neoplasms, Plasma Cell Leukemia, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |