Study on Limited-Duration Teclistamab for Patients with Multiple Myeloma

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05932680

This clinical trial is exploring whether patients with multiple myeloma who have responded well to teclistamab treatment can safely stop the medication after 6 to 9 months, instead of continuing indefinitely. The study aims to see if this approach can reduce side effects and still keep the cancer under control.

Patient Parameters

Program Overview

This study is testing a new approach for using the drug teclistamab in patients with multiple myeloma. Normally, teclistamab is given continuously, but this trial will see if patients who have responded well to the drug can stop taking it after 6 to 9 months. If the cancer shows signs of returning, the treatment can be restarted. The goal is to find out if stopping the drug early can reduce side effects like infections, while still keeping the cancer in check. Researchers will also look at factors that might predict which patients will do well with this limited-duration treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to provide written consent.
  • Must have started teclistamab treatment 6-9 months before joining the study and received an average dose of at least 1.5 mg/kg per month.
  • Must have received a dose of teclistamab within 4 weeks before joining the study.
  • Must have had measurable multiple myeloma within 1 month before starting teclistamab.
  • Must have achieved a very good partial response (VGPR) or better to teclistamab and still be responding at the time of joining the study.
  • Before starting teclistamab, must have been treated with a proteasome inhibitor, a thalidomide analog (like lenalidomide or pomalidomide), and an anti-CD38 antibody, and meet one of the following:
    • Have had at least 3 previous lines of therapy.
    • Be resistant to both a proteasome inhibitor and a thalidomide analog.
  • Must have had a performance status score of 0-2 when starting teclistamab and 0-1 when joining the study.
  • Must not have systemic amyloidosis or POEMS syndrome.

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