Teclistamab with daratumumab for newly diagnosed multiple myeloma with light chain amyloidosis

Trial details

Who runs it

Shanghai Zhongshan Hospital

Trial code

NCT07638683

Record updated

3 August 2026

Original description

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:Read full original descriptionShow less

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)

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

Inclusion: 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).

Exclusion: 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; Any other condition that the investigator considers unsuitable for study participation; Pregnant or lactating female; Currently participating in another interventional study.

ClinicalTrials.gov NCT07638683