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

NCT ID: NCT03389347

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2026-12-19

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.

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.

Conditions

Plasma Cell Leukemia; Recurrent Multiple Myeloma; Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of bone marrow aspirate and blood

High Throughput Screening

Intervention Type: DEVICE

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

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Biospecimen Collection

Undergo collection of bone marrow aspirate and blood

Intervention Type: PROCEDURE

High Throughput Screening

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

Intervention Type: DEVICE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

High Throughput Assay

Eligibility Criteria

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 > 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danai Dima, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2017-02204

Identifier Type: REGISTRY

Identifier Source: secondary_id

9944

Identifier Type: OTHER

Identifier Source: secondary_id

RG1017011

Identifier Type: OTHER

Identifier Source: secondary_id

9944

Identifier Type: -

Identifier Source: org_study_id