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Tests treatment safety and results for Multiple Myeloma
Official title A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).
ClinicalTrials.gov ID: NCT07638683
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as Daratumumab.
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
- The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL). It will also learn about the safety of this combination.
- 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
- Age ≥18 years, any sex/gender
- Diagnosis of multiple myeloma according to IMWG criteria
- Histopathologic diagnosis of AL amyloidosis confirmed by:
- Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:
- Immunohistochemistry and/or immunofluorescence
You likely can't join if
- Prior anti-myeloma therapy or stem cell transplantation
- Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM...
- Active infection or autoimmune disease
- Uncontrolled diabetes, hypertension, or other comorbidities
- Pregnant or lactating female
- Currently participating in another treatment study
See the full eligibility criteria
- Age ≥18 years, any sex/gender
- Diagnosis of multiple myeloma according to IMWG criteria
- Histopathologic diagnosis of AL amyloidosis confirmed by:
- Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:
- Immunohistochemistry and/or immunofluorescence
- Mass spectrometry
- Electron microscopy/immunoelectron microscopy
- Measurable disease at screening
- Newly diagnosed, no prior anti-plasma cell therapy
- Adequate laboratory values:
- Hemoglobin ≥7.5 g/dL
- Absolute neutrophil count ≥1.0×10⁹/L
- Platelet count ≥70×10⁹/L (platelet transfusion acceptable; \>50×10⁹/L if ≥50% bone marrow nucleated cells are plasma cells)
- ALT ≤2.5× upper limit of normal (ULN)
- AST ≤2.5× ULN
- Total bilirubin ≤2.0× ULN
- Creatinine clearance ≥30 mL/min
- Corrected serum calcium ≤14 mg/dL
- Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
- Voluntarily signed informed consent form (ICF)
- Prior anti-myeloma therapy or stem cell transplantation
- Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or...
- Active infection or autoimmune disease
- Uncontrolled diabetes, hypertension, or other comorbidities
- Pregnant or lactating female
- Currently participating in another treatment study
- Any other condition that the investigator considers unsuitable for study participation
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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 Shanghai, China. 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.