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New treatment option for Multiple Myeloma, Newly Diagnosed
Official title Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
ClinicalTrials.gov ID: NCT06758375
What this study is testing
What is Low-dose teclistamab?
Low-dose teclistamab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for multiple myeloma, newly diagnosed.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
- Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.
You likely can't join if
- 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...
- Severe active infection secondary to viruses, bacteria or fungi.
- Pulmonary disease requiring supplemental oxygen.
- History of allogeneic or autologous hematopoietic cell transplantation.
See the full eligibility 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...
- Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Monterrey, Nuevo León, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monterrey, Nuevo León, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.