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Limited-duration Teclistamab
NCT05932680 · View on ClinicalTrials.gov ↗
Study Summary
This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager (anti-BCMAxCD3 bispecific antibody), will be offered monitored drug discontinuation. Teclistamab is typically dosed on a regular schedule (every 1-4 weeks) indefinitely until disease progression ("continuous therapy"). Here, a limited-duration regimen will be studied in which patients achieving ≥VGPR after 6-9 months of standard teclistamab dosing will discontinue therapy and resume if laboratory or clinical parameters suggest early disease progression ("limited-duration therapy"). Patients will enter the clinical trial protocol after completing 6-9 months of standard teclistamab monotherapy and achieving ≥VGPR. The study's hypothesis is that the failure probability six months after stopping teclistamab in this patient population will be non-inferior compared to that of historical controls treated with continuous therapy. Reducing drug exposure may be beneficial by reducing risk of infection and reducing anti-BCMA selective pressure toward generation of BCMA-negative relapses. Analysis of minimal residual disease (MRD), tumor features, and bone marrow microenvironment parameters, which will be pursued as exploratory correlative analyses in this study, may identify factors that predict durable response to limited-duration therapy and thereby enable more precise selection of patients likely to benefit from this approach. A subset of patients will be enrolled on a biomarker study for analysis of these exploratory endpoints.
Conditions Studied
Interventions
- OTHER Off Drug Surveillance
Study Locations (5)
Pennsylvania
- Abramson Cancer Center at University of Pennsylvania — Philadelphia
- Thomas Jefferson University, Honickman Center — Philadelphia
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
New York
- Columbia University — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05932680
The ClinicalTrials.gov registry entry for NCT05932680 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 332 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Myeloma Multiple appearing as the primary indexed condition, and to 1 intervention — of which Off Drug Surveillance is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05932680 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Pennsylvania, Arkansas, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05932680 about?
NCT05932680 is a clinical study titled "Limited-duration Teclistamab". This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed...
What is the current status of trial NCT05932680?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2023-07-05. Estimated completion is 2027-01.
What conditions does trial NCT05932680 study?
This clinical trial studies the following conditions: Myeloma Multiple. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05932680?
The interventions under investigation include: Off Drug Surveillance (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05932680?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 332 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05932680 being conducted?
This trial has 5 study locations across Arkansas, Iowa, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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