Could a break from teclistamab be safe for myeloma patients?
NCT ID NCT05932680
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether people with multiple myeloma who have responded very well to teclistamab can safely stop taking it for a while. Instead of staying on the drug indefinitely, participants who have had a good response for 6-9 months will pause treatment and be closely monitored. If the cancer shows signs of returning, they will restart teclistamab. The goal is to see if this drug holiday works as well as continuous therapy, while reducing side effects like infections and the risk of the cancer becoming resistant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- teclistamab
- What this could lead to
- If successful, this could allow some multiple myeloma patients to take a break from teclistamab without the cancer returning quickly, reducing infections and drug resistance.
- What could go wrong
- This is a small, early-phase study (75 people) without a comparison group. The cancer may return sooner than expected, and not all patients will benefit from stopping therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must be age ≥18 and able to give written, informed consent. * Participants must have initiated teclistamab (first full dose) 6-9 months prior to enrollment and received an average teclistamab dose of at least 1.5 mg/kg/month since the date of the first 1.5 mg/kg dose. * Participants must have received a teclistamab dose within 4 weeks prior to enrollment. * Participants must have had measurable disease according to IMWG criteria within 1 month prior to teclistamab initiation or first full teclistamab dose * Participants must have achieved a confirmed VGPR or better to teclistamab therapy at any assessment prior to enrollment and have ongoing response (i.e., no disease progression) at time of enrollment per IMWG consensus criteria (Appendix 14.3). * Prior to initiating teclistamab, participants must have received therapy with a proteasome inhibitor, thalidomide analog (lenalidomide or pomalidomide), and an anti-CD38 antibody and meet one of the following criteria: 1. ≥3 prior lines of therapy (with lines-of-therapy delineated according to IWMG guidelines) 2. Refractory to both a proteasome inhibitor and a thalidomide analog. * Participants must have had an ECOG performance status of 0-2 at time of teclistamab initiation; in addition, ECOG performance status must be 0-1 at time of enrollment. * Participants must not have known diagnoses of systemic amyloidosis or POEMS syndrome.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abramson Cancer Center at University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Columbia University
RECRUITINGNew York, New York, 10032-3702, United States
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Thomas Jefferson University, Honickman Center
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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University of Arkansas for Medical Sciences
RECRUITINGLittle Rock, Arkansas, 72205, United States
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University of Iowa Hospitals and Clinics
RECRUITINGIowa City, Iowa, 52242, United States
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