UPCC 08423: Phase 2, Single-Arm, Non-Inferiority Study Of Limited-Duration Teclistamab For Relapsed Refractory Multiple Myeloma

Study on Limited-Duration Therapy for Relapsed Refractory Multiple Myeloma

Enrolling By Invitation
18 years or above
All
Phase 2
75 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myeloma Multiple
  • Age: 18 years or above
  • Gender: All

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.

This study investigates a limited-duration therapy approach for patients with relapsed refractory multiple myeloma who have shown a very good partial response or better after receiving teclistamab. This study aims to determine if stopping teclistamab treatment after 6 to 9 months is as effective as continuous treatment in preventing disease progression.

Participants will be monitored after discontinuing teclistamab, and treatment will resume if there are signs of disease progression. The study will also explore factors such as minimal residual disease and bone marrow characteristics to predict which patients might benefit most from this limited-duration therapy.

  • Who can participate: Adults aged 18 and older who have been treated with teclistamab for 6-9 months and achieved a very good partial response or better can participate. Prior treatments must include a proteasome inhibitor, thalidomide analog, and an anti-CD38 antibody, and they must not have systemic amyloidosis or POEMS syndrome.
  • Study details: Participants will stop teclistamab treatment after achieving a very good partial response or better and will be monitored for signs of disease progression. Treatment will resume based on clinical assessments if necessary.
Updated on 01 Oct 2025. Study ID: 23-0532
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