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).

Plain-language summary

This study evaluates the efficacy and safety of teclistamab combined with daratumumab (Tec-Dara) in patients newly diagnosed with multiple myeloma who also have light chain (AL) amyloidosis. It can include adults aged 18 or older with multiple myeloma by IMWG criteria and confirmed AL amyloidosis who have not received prior anti-plasma cell therapy. It is being carried out in Phase 2 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Shanghai Zhongshan Hospital

Intervention

Teclistamab

Start date

5/22/2026

Estimated completion

12/30/2028

Countries

China

Related genes

Locations

• Shanghai, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Age ≥18 years, any sex/gender
2. Diagnosis of multiple myeloma according to IMWG criteria
3. Histopathologic diagnosis of AL amyloidosis confirmed by:

   * Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:

     1. Immunohistochemistry and/or immunofluorescence
     2. Mass spectrometry
     3. Electron microscopy/immunoelectron microscopy
4. Measurable disease at screening
5. Newly diagnosed, no prior anti-plasma cell therapy
6. 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
7. Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
8. Voluntarily signed informed consent form (ICF)

Exclusion Criteria:

1. Prior anti-myeloma therapy or stem cell transplantation
2. 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
3. Active infection or autoimmune disease
4. Uncontrolled diabetes, hypertension, or other comorbidities
5. Pregnant or lactating female
6. Currently participating in another interventional study
7. Any other condition that the investigator considers unsuitable for study participation