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NCT03389347 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-05-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Actionable Assay Response

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outcome · NOT POSTED

Overall Response Rate to the Therapy Chosen After Performing the Assay

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Device: High Throughput Screening
    3. Other: Laboratory Biomarker Analysis
    label
    Device feasibility (high-throughput assay, sequencing)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Device feasibility (high-throughput assay, sequencing)
    description
    Undergo collection of bone marrow aspirate and blood
    name
    Biospecimen Collection
    type
    PROCEDURE
  2. arm Group Labels
    1. Device feasibility (high-throughput assay, sequencing)
    description
    Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay
    name
    High Throughput Screening
    other Names
    1. High Throughput Assay
    type
    DEVICE
  3. arm Group Labels
    1. Device feasibility (high-throughput assay, sequencing)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
OTHER
Enrollment
count
40
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With Actionable Assay Response
    time Frame
    Up to 21 days
secondary Outcomes
  1. description
    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.
    measure
    Overall Response Rate to the Therapy Chosen After Performing the Assay
    time Frame
    Up to 2 years
Full 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.
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      payload
      clinical indication matching status
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      true
      id
      nct-edge-af1ff11b452b207fe1e3
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT03389347
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      4e50ce4bd9132f15c4f9885b19e80c46ee76c6a155b8a750162805edd5776733

    Preserved source evidence · Not medical advice