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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Multiple Myeloma; Plasma Cell Leukemia; Recurrent Multiple Myeloma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection; Device: High Throughput Screening

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew J. Cowan; Phone Number: 206-606-7348; Email: ajcowan@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Andrew J. Cowan
      • Contact: Andrew J. Cowan; Phone Number: 206-606-7348; Email: ajcowan@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.	Other: Laboratory Biomarker Analysis; Correlative studies; 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 Names: High Throughput Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actionable assay result	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Andrew J. Cowan, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia; Leukemia, Plasma Cell
• Other Study ID Numbers: 9944 (Other Identifier: CTEP); NCI-2017-02204 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG1017011 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes