ClinicalTrials.gov record 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).

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 study evaluates the combination of teclistamab and daratumumab in people with newly diagnosed multiple myeloma who also have light-chain (AL) amyloidosis. All participants receive the two drugs by subcutaneous injection on a scheduled dosing plan for up to 24 cycles (about 2 years) or until disease progression or unacceptable toxicity. The study measures disease outcomes (including 1‑year progression-free survival, hematologic and organ responses, and MRD) and collects safety data.

What it is studying. The study measures the 1‑year progression-free survival (PFS) rate for the combination and compares it with historical PFS data (baseline ~50%). It also records hematologic response rates (ORR, VGPR, CR), minimal residual disease (MRD) negativity, organ response for AL amyloidosis, time to and duration of response, time to next treatment, and characterizes treatment-related adverse events (for example cytokine release syndrome, neurotoxicity, infections, and hematologic toxicities).

What the researchers hope to learn. To determine the 1‑year PFS rate with the teclistamab plus daratumumab combination compared with historical data and to measure hematologic and organ response rates, MRD negativity, time to response, duration of response, progression-free survival, time to next treatment, and to characterize treatment-related adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Teclistamab

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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:
  • Immunohistochemistry and/or immunofluorescence
  • Mass spectrometry
  • Electron microscopy/immunoelectron microscopy
  • Measurable disease at screening
  • Newly diagnosed, no prior anti-plasma cell therapy
  • 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
  • Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
  • Voluntarily signed informed consent form (ICF)

Exclusion criteria

  • Prior anti-myeloma therapy or stem cell transplantation
  • 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
  • Active infection or autoimmune disease
  • Uncontrolled diabetes, hypertension, or other comorbidities
  • Pregnant or lactating female
  • Currently participating in another interventional study
  • Any other condition that the investigator considers unsuitable for study participation

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive two study drugs by subcutaneous injection: teclistamab with step‑up dosing (0.06, 0.3, 1.5 mg/kg on early days, then 1.5 mg/kg weekly then less frequent maintenance dosing) combined with daratumumab 1800 mg on a set schedule. Treatment continues until disease progression, unacceptable toxicity, or up to 24 cycles (about 2 years). They will have disease assessments about every 28 days (±7 days), including laboratory tests for blood/organ response, and will provide bone marrow samples for MRD testing and RNA sequencing. Study staff will monitor and record side effects and adverse events throughout participation.

How the study is structured. Phase 2, open-label, single-group interventional trial. Everyone enrolled receives teclistamab (subcutaneous step-up dosing then maintenance) together with subcutaneous daratumumab on a planned schedule; there is no placebo or randomization. Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 cycles; participants have regular disease assessments and bone marrow sampling for MRD.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 22, 2026
Primary completion
Jul 30, 2028 (estimated)
Study completion
Dec 30, 2028 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Aug 3, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shanghai Zhongshan Hospital
Principal investigator
Peng Liu, Professor, Chief Physician
Shanghai Zhongshan Hospital
Collaborators
  • Johnson & Johnson

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

progression-free survival
The length of time during and after treatment that a person lives without the condition getting worse, as defined by the study.
VGPR
A response category used in some blood conditions meaning the disease marker has fallen a great deal but not disappeared. The exact definition depends on the condition and the study.
MRD
Very small amounts of disease that remain after treatment and can only be found with highly sensitive tests. 'MRD-negative' means none was detected at the test's limit. The exact test and threshold depend on the condition and the study.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Absolute neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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