TriangleNCT03389347 · STUDY IN CONTEXT
High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT03389347
- trial label
- High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
- applicability
- unclear
- applicability note
- Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT03389347
- outcome key
- om-0000
- source section id
- NCT03389347-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Actionable Assay Response
- endpoint definition
- 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.
- time origin
- Up to 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 40 patients enrolled, 35 obtained actionable response from the assay within 21 days.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT03389347
- outcome key
- om-0001
- source section id
- NCT03389347-om-0001
- source outcome index
- 1
- endpoint
- Overall Response Rate to the Therapy Chosen After Performing the Assay
- endpoint definition
- 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.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT03389347
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Device Feasibility (High-throughput Assay, Sequencing)
- regimen
- 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
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03389347-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT03389347
- harm key
- EG000
- source section id
- NCT03389347-ae
- event group key
- EG000
- event group label
- Device Feasibility (High-throughput Assay, Sequencing)
- serious affected
- 0
- serious at risk
- 40
- other affected
- 0
- other at risk
- 40
- frequency threshold
- 5
- collection period
- 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.
- event definition
- Adverse event collection started at time of consent and ended when patients moved to follow-up.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice