OncoMatch/Clinical Trials/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).
Is NCT07638683 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Teclistamab for multiple myeloma.
Treatment: Teclistamab — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Multiple Myeloma
Prior therapy
Cannot have received: anti-myeloma therapy
Prior anti-myeloma therapy
Cannot have received: stem cell transplant
Prior stem cell transplantation
Lab requirements
Blood counts
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)
Kidney function
Creatinine clearance ≥30 mL/min
Liver function
ALT ≤2.5× ULN; AST ≤2.5× ULN; Total bilirubin ≤2.0× ULN
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× ULN; AST ≤2.5× ULN; Total bilirubin ≤2.0× ULN; Creatinine clearance ≥30 mL/min; Corrected serum calcium ≤14 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07638683 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages