Clinical trial · Interventional
Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
NCT06758375CI-TRIAL-00087466recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma, Newly Diagnosed | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose teclistamab | Drug | Teclistamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients receiving 3 cycles of VRd followed by low-dose teclistamab.
- interventionNames
- Drug: Low-dose teclistamab
Primary outcomes (1)
- measure
- To determine general response
- timeFrame
- 18 months after last teclistamab dose
- description
- Evaluated according to the IMWG response criteria including MRD status.
Secondary outcomes (2)
- measure
- To determine response duration
- timeFrame
- Up to 18 months after last teclistamab dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDGirgis S, Lin SXW, Pillarisetti K, Banerjee A, Stephenson T, Ma X, Shetty S, Yang TY, Hilder BW, Jiao Q, Hanna B, Adams HC 3rd, Sun YN, Sharma A, Smit J, Infante JR, Goldberg JD, Elsayed Y. Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. Target Oncol. 2022 Jul;17(4):433-439. doi: 10.1007/s11523-022-00893-y. Epub 2022 Jun 24. PMID 35749004
- BACKGROUNDUsmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10. PMID 34388396