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

Trial Details

NCT ID

NCT07638683

Phase

PHASE2

Sponsor

Shanghai Zhongshan Hospital

Status

RECRUITING

Cancer Type

Newly Diagnosed Multiple Myeloma

Interventions

• Teclistamab

Locations (sample)

• Shanghai, China|31.22222,121.45806

Key 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:

For full eligibility, visit ClinicalTrials.gov.

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