Limited-duration Teclistamab

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05932680
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Myeloma Multiple

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Off Drug Surveillance — OTHER
    After stopping teclistamab, participants will be monitored monthly by standard serum paraprotein studies for disease progression. Participants will resume teclistamab at time of disease progression. After Teclistamab therapy re-initiation on-study, monthly response assessments and data for other study endpoints will be obtained. All participants will undergo peripheral blood collection for correlative research studies at baseline and every two months on-study. Participants who enroll on the biomarker sub-study will undergo bone marrow examination and peripheral blood collection for correlative studies at study entry, at time of disease progression and at six months from enrollment.

Study Details

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.

Key Dates

Start date
Jul 5, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Off Drug Surveillance
    Participants will stop receiving teclistamab and will be monitored closely for growth of their multiple myeloma. Participants will restart teclistamab if their multiple myeloma starts to grow.

Primary Outcome Measure

Failure free at six months following teclistamab discontinuation [ Time Frame: Six months after teclistamab discontinuation ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Carolina Schinke, MD
[email protected]
501-686-8230
Carolina Schinke, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Francesca Nugent
[email protected]
319-356-1727
Hira Shaikh, MD (PRINCIPAL_INVESTIGATOR)
Christopher Strouse, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032-3702
George Mellgard
[email protected]
212-342-5162
Rajshekar Chakraborty, MD (PRINCIPAL_INVESTIGATOR)
Divaya Bhutani, MD (PRINCIPAL_INVESTIGATOR)
Abramson Cancer Center at University of PennsylvaniaPhiladelphiaPennsylvania19104
Alfred Garfall, MD
[email protected]
215-349-8334
Thomas Jefferson University, Honickman CenterPhiladelphiaPennsylvania19107
Ariel Kobylak
[email protected]
267-408-7961
Lizza Waugh
[email protected]
Beatrice Razzo, MD (PRINCIPAL_INVESTIGATOR)
Adam Binder, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, ARUniversity of Iowa Hospitals and Clinics· Iowa City, IAColumbia University· New York, NYAbramson Cancer Center at University of Pennsylvania· Philadelphia, PAThomas Jefferson University, Honickman Center· Philadelphia, PA

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