Trial · NCT06140524
A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
NCT06140524, Phase 2, Recruiting, Regeneron Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma. Trials, record NCT06140524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06140524
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
- NCT number
- NCT06140524
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 116 participants, estimated
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM)
- Interventions
- Linvoseltamab
- First posted
- 2023-11-20
- Last updated
- 2026-07-08
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Adverse Events Interest (AEI) during the safety observation period | 35 days | Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules |
| Primary | Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period | 35 days | Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Primary | Severity of TEAEs during the safety observation period | 35 days | Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Primary | Achievement of Complete Response (CR) as determined by the investigator | Up to 5.5 years | Part 2 |
| Secondary | Frequency of TEAEs | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Severity of TEAEs | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Frequency of Serious Adverse Events (SAEs) | Up to 5.5 years | |
| Secondary | Severity of SAEs | Up to 5.5 years | |
| Secondary | Frequency of laboratory abnormalities | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
| Secondary | Severity of laboratory abnormalities | Up to 5.5 years | As assessed by the NCI-CTCAE grading system version 5 (for all grades) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06140524
GET https://conductscience.org/api/trials/v1/NCT06140524/registered