Limited-duration treatment with teclistamab for multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a limited-duration treatment approach using teclistamab, a bispecific antibody targeting B-cell maturation antigen, in patients with multiple myeloma who have achieved a very good partial response after 6 to 9 months of standard therapy. Participants will discontinue teclistamab treatment while being closely monitored for any signs of disease progression. The study aims to determine if this limited-duration therapy can maintain patient responses without the need for continuous treatment. The trial is designed as a single-arm, non-inferiority study to evaluate the effectiveness of this approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• Abramson Cancer Center at University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Thomas Jefferson University, Honickman Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Alfred Garfall, MD — Penn Medicine
• Study coordinator: Leonard Fiannaca, MS
• Email: Leonard.Fiannaca@pennmedicine.upenn.edu
• Phone: 215-662-3173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis

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• Quadruplet induction plus autologous transplant followed by teclistamab maintenance for plasma cell leukemia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.