Actively Recruiting
Phase 2 Single-Arm Non-Inferiority Study of Limited-Duration Teclistamab for Relapsed Refractory Multiple Myeloma
Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-10-01
75
Participants Needed
5
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a limited-duration treatment approach with teclistamab, a drug that targets B-cell maturation antigen (BCMA), for patients with relapsed or refractory multiple myeloma who have achieved a very good partial response or better after 6 to 9 months of standard teclistamab therapy. This phase 2, single-arm study aims to test whether stopping teclistamab after this response is not worse than continuing treatment indefinitely, with the hope to reduce risks like infection and treatment resistance. The study also explores biological markers that might predict which patients can safely stop treatment. Participants who have completed 6 to 9 months of standard teclistamab dosing and achieved at least a very good partial response will discontinue the drug and enter a monitoring phase. They will be watched closely with monthly serum tests to detect early signs of disease progression. If progression is detected, teclistamab treatment will be restarted. Some participants will take part in a biomarker sub-study involving additional blood and bone marrow samples to better understand factors linked to durable responses. During the study, participants will have monthly assessments after stopping teclistamab, including blood tests and response monitoring. Those resuming treatment will also be closely followed with monthly evaluations. Research samples will be collected periodically to analyze disease and immune system changes. The primary measure is whether patients remain free of treatment failure six months after stopping teclistamab. Secondary outcomes include time to progression, survival rates, infection rates, quality of life, and response to restarting teclistamab. The study plans to follow participants for up to two years after drug discontinuation.
CONDITIONS
Brief Title
Limited-duration Teclistamab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be age 18 or older and able to give written, informed consent.
- Participants must have started teclistamab treatment 6 to 9 months before enrollment.
- Participants must have received an average teclistamab dose of at least 1.5 mg/kg/month since the first full dose.
- Participants must have had measurable disease within 1 month before starting teclistamab.
- Participants must have achieved a confirmed very good partial response or better to teclistamab before enrollment and have no disease progression at enrollment.
- Participants must have prior therapy with a proteasome inhibitor, a thalidomide analog, and an anti-CD38 antibody, and meet one of these: have had 3 or more prior therapy lines or be refractory to both a proteasome inhibitor and a thalidomide analog.
- Participants must have an ECOG performance status of 0 to 2 at teclistamab start and 0 to 1 at enrollment.
- Participants must not have systemic amyloidosis or POEMS syndrome.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years following teclistamab discontinuation
Participants stop receiving teclistamab and are monitored monthly for disease progression using standard serum paraprotein studies. Participants will resume teclistamab if their multiple myeloma starts to grow. Peripheral blood is collected at baseline and every two months for correlative research studies. Those in the biomarker sub-study undergo additional bone marrow and blood collections at study entry, at disease progression, and six months after enrollment.
Monthly visits for disease monitoring and peripheral blood collections every two months; additional assessments for biomarker sub-study participants
Trial Site Locations
Total: 5 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Columbia University
New York, New York, United States, 10032-3702
Actively Recruiting
4
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Thomas Jefferson University, Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
L
Leonard Fiannaca, MS
A
Alfred Garfall, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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