Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates the efficacy and safety of teclistamab in combination with daratumumab (Tec-Dara) in adults with newly diagnosed multiple myeloma and concurrent light chain amyloidosis. Participants receive escalating and then maintained doses of teclistamab by subcutaneous injection alongside daratumumab, with treatment cycles spanning up to 24 cycles. The study will measure 1-year progression-free survival compared with historical data, hematologic response rates, organ responses, and safety outcomes. Eligibility requires confirmed MM and AL amyloidosis, measurable disease, no prior anti-plasma cell therapy, and adequate organ function. The trial is led by Shanghai Zhongshan Hospital with Johnson & Johnson as a collaborator and is conducted at a Shanghai site.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhongshan Hospital Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Peng Liu — Fudan University
• Study coordinator: Peng Liu
• Email: liu.peng@zs-hospital.sh.cn
• Phone: +86-021-64041990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination treatment for high-risk smoldering multiple myeloma

  This study is testing two different combination treatments to see which one helps people with high-risk smoldering multiple myeloma delay their disease from getting worse.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06100237

• Combining teclistamab and talquetamab with daratumumab and lenalidomide for newly diagnosed multiple myeloma

  This study is testing two new treatment combinations for people with newly diagnosed multiple myeloma to see if they work better than the standard treatment.

  Recruiting at 66 sites Phase 3 Janssen Research & Development, LLC · Gilbert, Arizona and 269 other locations · NCT05552222

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• A comparison of JNJ-79635322 and teclistamab in relapsed or refractory multiple myeloma

  This study tests whether JNJ-79635322 works differently from teclistamab in people with relapsed or refractory multiple myeloma who have had prior therapy.

  Recruiting at 173 sites Phase 3 Janssen Research & Development, LLC · Birmingham, Alabama and 172 other locations · NCT07518186

• Maintaining myeloma with less frequent daratumumab plus lenalidomide

  This phase 2 study tests a reduced-dosing schedule of daratumumab with lenalidomide to maintain remission in adults with multiple myeloma after stem cell transplant.

  Recruiting Phase 2 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07485647

• GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma

  This trial tests whether GR1803 injection works better than daratumumab combined with pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma who have had one to three prior treatments.

  Recruiting Phase 3 Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Tianjin · NCT07452198

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.