Limited-duration treatment with teclistamab for multiple myeloma
Phase 2, Single-Arm, Non-Inferiority Study Of Limited-Duration Teclistamab For Relapsed Refractory Multiple Myeloma
PHASE2 · Abramson Cancer Center at Penn Medicine · NCT05932680
This study is testing if a short-term treatment with teclistamab can help people with multiple myeloma keep their positive response after standard therapy without needing to stay on treatment continuously.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine (other) |
| Drugs / interventions | teclistamab |
| Locations | 5 sites (Little Rock, Arkansas and 4 other locations) |
| Trial ID | NCT05932680 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have achieved a very good partial response to teclistamab after 6 to 9 months of treatment.
Not a fit: Patients who have not achieved a very good partial response or those with progressive disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the duration of treatment for patients while maintaining their response to therapy.
How similar studies have performed: While limited-duration therapies are being explored in various contexts, this specific approach with teclistamab is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Little Rock, Arkansas and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myeloma Multiple