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
Phase 2
Interventional Study
Multiple Myeloma
AL Amyloidosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Other
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About This Trial
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 7…
Trial Locations
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Eligibility Criteria
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:
…
Contacts