NCT03389347 · ADVERSE EVENTS

Adverse events

High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia · Source last updated 2026-05-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse event collection started from the time of signing consent until the time at which assay results are provided to the patient and their treating physician, up to 6 weeks post-enrollment.
Other-event reporting threshold: 5%

Adverse event collection started at time of consent and ended when patients moved to follow-up.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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. Biospecimen Collection: Undergo collection of bone marrow aspirate and blood High Throughput Screening: Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay Laboratory Biomarker Analysis: Correlative studies	0 / 40	0 / 40	26 / 40

Group identifiers: EG000: Device Feasibility (High-throughput Assay, Sequencing)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

description

Adverse event collection started at time of consent and ended when patients moved to follow-up.

event Groups

deaths Num Affected
26
deaths Num At Risk
40
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. Biospecimen Collection: Undergo collection of bone marrow aspirate and blood High Throughput Screening: Anti-tumor drugs are tested against myeloma cells in the laboratory, in a high-throughput drug sensitivity assay Laboratory Biomarker Analysis: Correlative studies
id
EG000
other Num Affected
0
other Num At Risk
40
serious Num Affected
0
serious Num At Risk
40
title
Device Feasibility (High-throughput Assay, Sequencing)

frequency Threshold

time Frame

Adverse event collection started from the time of signing consent until the time at which assay results are provided to the patient and their treating physician, up to 6 weeks post-enrollment.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice