Limited-duration Teclistamab
Purpose
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.
Condition
- Myeloma Multiple
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Teclistamab is the study drug. The intervention is the cessation of the drug.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72205
Iowa City 4862034, Iowa 4862182 52242
New York 5128581, New York 5128638 10032-3702
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19107
More Details
- NCT ID
- NCT05932680
- Status
- Recruiting
- Sponsor
- Abramson Cancer Center at Penn Medicine