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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 : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Plasma Cell Leukemia Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Device: High-throughput assay

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the frequency of obtaining an actionable result from the assay and to estimate feasibility as defined as a frequency of at least 50%.

II. To test patient cells in a high-throughput assay against individual drugs and drug combinations within 21 days, to enable optimal choice of drug combinations for therapy.

SECONDARY OBJECTIVES:

I. To assess the response rate among patients treated after physicians are presented with the testing results.

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Anticipated Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : February 1, 2022


Arms and Interventions

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.
Procedure: Biospecimen Collection
Undergo collection of bone marrow aspirate and blood
Other: Laboratory Biomarker Analysis
Correlative studies
Device: High-throughput assay
Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall response rate to the therapy chosen after performing the assay, as assessed by the International Myeloma Working Group (IMWG) response criteria [ Time Frame: Up to 2 years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of multiple myeloma with documented relapsed or refractory/relapsed disease according to international Myeloma Working Group (IMWG) criteria, or relapsed/refractory plasma cell leukemia
  • Measurable disease defined by 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)
    • Serum free light chain (FLC) >= 10 mg/dL and abnormal serum kappa to lambda ratio
  • 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) >=2
  • 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
  • 12 lead electrocardiogram (ECG) with corrected QT interval (QTc) =< 470 msec
  • Absolute neutrophil count (ANC) > 1000
  • Platelets > 75,000
  • Hemoglobin (Hb) > 8
  • Total bilirubin < 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
  • Estimated creatinine clearance by Cockcroft-Gault > 45
  • Expected survival is > 100 days

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 study initiation
  • 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
  • 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 therapy (RT) within 2 weeks (not including limited radiation used for palliation of bone pain)
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Andrew J. Cowan         
Principal Investigator: Andrew J. Cowan         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrew Cowan Fred Hutch/University of Washington Cancer Consortium
More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03389347     History of Changes
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 )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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