Low-dose teclistamab for newly diagnosed multiple myeloma patients

Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.

This study tests if a low dose of teclistamab can help newly diagnosed multiple myeloma patients stay in remission after initial treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez (Academic / other)
• Drugs / interventions: teclistamab
• Locations: 1 site (Monterrey, Nuevo León)
• Trial ID: NCT06758375 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label study that evaluates the efficacy and safety of low-dose teclistamab as a consolidation treatment for patients with newly diagnosed multiple myeloma after receiving three cycles of induction therapy with bortezomib, lenalidomide, and dexamethasone. Participants will receive four doses of teclistamab at 1.0 mg/kg subcutaneously, and their clinical response will be assessed according to established criteria. Those achieving a complete response will be monitored for measurable residual disease, while others may receive additional treatment based on their response. The study aims to provide insights into the effectiveness of teclistamab in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed multiple myeloma and an ECOG performance status of 0 or 1.

Not a fit: Patients with a history of previous treatment for multiple myeloma or those with severe active infections or other specified exclusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with newly diagnosed multiple myeloma by enhancing response rates and reducing disease progression.

How similar studies have performed: While this approach is novel in its specific application of teclistamab for newly diagnosed multiple myeloma, similar studies have shown promise with other therapies in this context.

Eligibility criteria

Inclusion Criteria:

* ≥18 years of age.
* Newly diagnosed multiple myeloma.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
* Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner.
* Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.

Exclusion Criteria:

* History of previous treatment for MM.
* Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis.
* Severe active infection secondary to viruses, bacteria or fungi.
* Pulmonary disease requiring supplemental oxygen.
* History of allogeneic or autologous hematopoietic cell transplantation.
* Vaccination with live attenuated virus in the 4 weeks prior to teclistamab administration.
* Major surgery during the 2 weeks prior to the first dose or absence of complete recovery from surgery.
* Presence of other concomitant malignancy.
* Hepatitis B and C virus infection or human immunodeficiency virus (HIV) infection.
* Cerebrovascular events or seizures in the last 6 months.
* Congestive heart failure class III-IV according to NYHA (New York Heart Association Stage).
* Acute myocardial infarction or history of coronary revascularization surgery in the last 6 months.
* Women of childbearing age: active pregnancy prior to the first administration of treatment.

Where this trial is running

Monterrey, Nuevo León

• Hospital Universitario Dr. Jose E. Gonzalez — Monterrey, Nuevo León, Mexico (Recruiting)

Study contacts

• Study coordinator: David Gomez-Almaguer, MD

Conditions Multiple Myeloma, Newly Diagnosed; Multiple myeloma; Teclistamab; Newly diagnosed multiple myeloma; Low-dose teclistamab