Trial Outcomes & Findings for High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia (NCT NCT03389347)
NCT ID: NCT03389347
Last Updated: 2026-05-08
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
40 participants
Up to 21 days
2026-05-08
Participant Flow
Of 55 screened participants, 40 met inclusion criteria and were enrolled.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
Baseline characteristics by cohort
| Measure |
Device Feasibility (High-throughput Assay, Sequencing)
n=40 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=41 Participants
|
|
Age, Continuous
|
62.33 years
STANDARD_DEVIATION 10.74 • n=41 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Of the 40 patients enrolled, 35 obtained actionable response from the assay within 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.
Outcome measures
| Measure |
Device Feasibility (High-throughput Assay, Sequencing)
n=40 Participants
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
|
|---|---|
|
Number of Participants With Actionable Assay Response
|
35 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsWill 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.
Outcome measures
Outcome data not reported
Adverse Events
Device Feasibility (High-throughput Assay, Sequencing)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place