Limited-duration Teclistamab

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating multiple myeloma, a type of blood cancer. The researchers want to find out if patients who have responded well to a medication called teclistamab for 6 to 9 months can safely stop taking it for a while without their cancer getting worse. Typically, patients continue taking teclistamab indefinitely until their disease progresses, but this trial is exploring whether a limited duration of treatment can be just as effective. Participants will be monitored closely after stopping the medication and can restart it if needed.

To be eligible for this trial, participants must be at least 18 years old and have been receiving teclistamab for 6 to 9 months with a good response to the treatment. They should have also previously received other specific treatments for their myeloma. During the study, participants will undergo regular check-ups to assess their health and response to stopping the medication. Additionally, some patients will participate in a special study to help researchers understand what factors might predict long-lasting benefits from this limited-duration therapy. This trial is currently recruiting participants, and both men and women are welcome to apply.

Gender

ALL

Eligibility 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.