A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumum… (NCT07638683) | Clinical Trial Compass
RecruitingPhase 2
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).
China30 participantsStarted 2026-05-22
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years, any sex/gender
. Diagnosis of multiple myeloma according to IMWG criteria
. Histopathologic diagnosis of AL amyloidosis confirmed by:
. Immunohistochemistry and/or immunofluorescence
. Mass spectrometry
. Electron microscopy/immunoelectron microscopy
. Measurable disease at screening
. Newly diagnosed, no prior anti-plasma cell therapy
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines teclistamab and daratumumab for people who have both multiple myeloma and AL amyloidosis at the same time — how does having both conditions affect whether this approach might be appropriate for me to discuss with my care team?
2Since this is a Phase II trial, what does that mean for how much is already known about the safety of giving teclistamab and daratumumab together, especially for someone whose organs may already be stressed by amyloidosis?
3The trial is measuring 1-year progression-free survival as its main goal — what does that tell us about what the researchers are most focused on proving, and how does that compare to the outcomes that matter most in my situation?
4Are there standard treatment options already available for newly diagnosed multiple myeloma with AL amyloidosis that my doctor would recommend I consider before or instead of enrolling in this study?
5Given that this trial is actively recruiting, what would the visit schedule and monitoring requirements look like, and is that something worth discussing in terms of how it fits with my current health and daily life??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-Year Progression-Free Survival (PFS) Rate
Timeframe: From the start of treatment to 1 year, or until disease progression or death, whichever occurs first
. 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