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

NCT03389347 | Active Not Recruiting Results DMC FDA Device

• 3 other identifiers: 9944NCI-2017-02204RG1017011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plasma Cell Leukemia; Recurrent Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 21 days

Secondary Outcomes (1)

• Overall Response Rate to the Therapy Chosen After Performing the Assay

  Up to 2 years

Study Arms (1)

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.

Procedure: Biospecimen Collection; Device: High Throughput Screening; Other: Laboratory Biomarker Analysis

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of bone marrow aspirate and blood

Device feasibility (high-throughput assay, sequencing)

High Throughput Screening DEVICE

Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay

Also known as: High Throughput Assay

Device feasibility (high-throughput assay, sequencing)

Laboratory Biomarker Analysis OTHER

Correlative studies

Device feasibility (high-throughput assay, sequencing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 \> 100 days

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Plasma Cell; Multiple Myeloma

Interventions

High-Throughput Screening Assays

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Danai Dima
• Organization: Fred Hutch Cancer Center

ddima@fredhutch.org

206 667-5000

Study Officials

• Danai Dima, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 3, 2018
• Study Start: February 14, 2018
• Primary Completion: December 19, 2024
• Study Completion (Estimated): December 19, 2026
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)