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).
Recruiting now · Phase 2
Conditions studied: Multiple Myeloma, AL Amyloidosis
In brief
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. The main questions it aims to answer are: Does Tec-Dara improve the 1-year progression-free survival rate compared to historical data (50% to 75%) in MM+AL patients? What are the rates of hematologic response (ORR, VGPR, CR, MRD negativity) and organ response in MM+AL patients treated with Tec-Dara? What medical problems do participants have when taking Tec-Dara? Participants will: Receive teclistamab subcutaneous injection with step-up dosing (0.06, 0.3, 1.5 mg/kg), followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24 Receive daratumumab subcutaneous injection 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24 Continue treatment until disease progression, unacceptable toxicity, or a maximum of 24 cycles Undergo disease assessments every 28 days (±7 days) including laboratory tests for hematologic and organ response evaluation Provide bone marrow samples for MRD and RNA sequencing analysis
Key facts
- Study ID
- NCT07638683
- Run by
- Shanghai Zhongshan Hospital
- People needed
- 30
- Starts
- 2026-05-22
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- 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)
You may not qualify 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, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or other malignancies within 3 years prior to enrollment
- Active infection or autoimmune disease
- Uncontrolled diabetes, hypertension, or other comorbidities
- Pregnant or lactating female
- Currently participating in another interventional study
- Any other condition that the investigator considers unsuitable for study participation
Where it is running
- Zhongshan Hospital Fudan University — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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