NCT07638683 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).
| NCT ID | NCT07638683 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-05-22 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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: 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
Contact & Investigator
Peng Liu
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT07638683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07638683 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07638683 currently recruiting?
Yes, NCT07638683 is actively recruiting participants. Contact the research team at liu.peng@zs-hospital.sh.cn for enrollment information.
Where is the NCT07638683 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07638683 clinical trial?
NCT07638683 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Peng Liu at Fudan University. The trial plans to enroll 30 participants.