Low-dose teclistamab for newly diagnosed multiple myeloma patients

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 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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: David Gomez-Almaguer, MD
• Email: dgomezalmaguer@gmail.com
• Phone: 528186756718

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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• A comparison of JNJ-79635322 and teclistamab in relapsed or refractory multiple myeloma

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• Teclistamab plus pomalidomide vs standard therapy for relapsed multiple myeloma

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• Teclistamab for recurrent or refractory plasmablastic lymphoma

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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.