Multiple MyelomaPhase 2NCT07638683
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).
A Phase 2 study testing Teclistamab in people with Multiple Myeloma and AL Amyloidosis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, AL Amyloidosis
- What is being tested?
- Teclistamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai
Jing Li, +86-18149780650, li.jing6@zs-hospital.sh.cn
About this study
Official title: 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)
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?
Read more
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
- Conditions
- Multiple Myeloma, AL Amyloidosis
- Being tested
- Teclistamab
- Keywords
- Multiple Myeloma, AL Amyloidosis, Teclistamab, Daratumumab
- Medical subject headings
- Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called Daratumumab
Teclistamab: A humanized IgG4-PAA bispecific antibody targeting BCMA and CD3. It bridges malignant plasma cells and CD3+ T cells, leading to T cell activation and perforin/granzyme-mediated lysis of BCMA+ tumor cells.
Daratumumab: A humanized IgG1κ monoclonal antibody targeting CD38, which induces tumor cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. It also enhances T cell-mediated anti-myeloma immunity by increasing cytotoxic T helper cells and depleting CD38+ immunoregulatory cells, thereby potentiating teclistamab's activity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Teclistamab (subcutaneous injection) with step-up dosing: 0.06 mg/kg, 0.3 mg/kg, and 1.5 mg/kg on Days 1, 3, and 5 of Cycle 1, 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.
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.
Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 cycles (approximately 2 years). Receives: Drug: Teclistamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Progression-Free Survival (PFS) Rate
The percentage of participants who are alive and free from disease progression at 1 year after initiation of Tec-Dara treatment. Progression is defined according to IMWG criteria, including increase in serum M protein, urine M protein, or serum free light chain; development of new bone lesions or soft tissue plasmacytomas; or hypercalcemia.
Measured: From the start of treatment to 1 year, or until disease progression or death, whichever occurs first
Secondary outcomes (9)
Hematologic Complete Response (Heme-CR) rate
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response. Heme-CR rate is the percentage of participants who achieve CR prior to subsequent anti-myeloma therapy, during or after the study treatment.
Measured: Up to 24 cycles (approximately 2 years)
Very Good Partial Response or Better (≥VGPR) Rate
Heme-VGPR is defined as a reduction in the dFLC to <40 mg/L. ≥VGPR rate is the percentage of participants achieving VGPR and CR prior to subsequent anti-myeloma therapy during or after the study treatment.
Measured: Up to 24 cycles (approximately 2 years)
Minimal Residual Disease (MRD) Negativity Rate
Proportion of participants achieving MRD negativity at a sensitivity threshold of 10^-5, assessed by next-generation flow cytometry (NGF) or next-generation sequencing (NGS). The MRD-negativity rate by 6 and 12 months will be reported descriptively.
Measured: 6 months and 12 months, and up to 24 cycles (approximately 2 years)
Organ Response Rate
Proportion of participants achieving organ response according to consensus criteria for AL amyloidosis, based on changes in NT-proBNP, cardiac troponin T/I, and estimated glomerular filtration rate (eGFR).
Measured: Up to 24 cycles (approximately 2 years)
Time to First Response
Time from the start of treatment to the first documented PR or better response according to IMWG criteria.
Measured: Up to 24 cycles (approximately 2 years)
Duration of Response
Time from the start of treatment to death from any cause.
Measured: Up to 3 years from study start
Median Progression-Free Survival
Time from the start of treatment to disease progression or death from any cause, whichever occurs first.
Measured: Up to 3 years from study start
Time to Next Treatment
Time from the start of treatment to the initiation of first subsequent anti-myeloma therapy.
Measured: Up to 3 years from study start
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0. A participant with multiple adverse events of the same preferred term will be counted once. Adverse events will be summarized by frequency, severity (graded by CTCAE v5.0), and causality, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, hematologic toxicities, and infusion-related reactions.
Measured: Through study completion, up to 12 months after the end of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start22 May 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638683
- Sponsor's protocol ID
- SHZS-MMAL-001
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07638683
- Acronym / sponsor ID
- SHZS-MMAL-001
- Conditions
- Multiple Myeloma, AL Amyloidosis
- Keywords
- Multiple Myeloma, AL Amyloidosis, Teclistamab, Daratumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 22 May 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: TeclistamabTeclistamab (subcutaneous injection) with step-up dosing: 0.06 mg/kg, 0.3 mg/kg, and 1.5 mg/kg on Days 1, 3, and 5 of Cycle 1, 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. 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. Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 cycles (approximately 2 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥18 years, any sex/gender
- Diagnosis of multiple myeloma according to IMWG criteria
- Histopathologic diagnosis of AL amyloidosis confirmed by:
- Measurable disease at screening
- Newly diagnosed, no prior anti-plasma cell therapy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: DaratumumabTeclistamab: A humanized IgG4-PAA bispecific antibody targeting BCMA and CD3. It bridges malignant plasma cells and CD3+ T cells, leading to T cell activation and perforin/granzyme-mediated lysis of BCMA+ tumor cells. Daratumumab: A humanized IgG1κ monoclonal antibody targeting CD38, which induces tumor cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. It also enhances T cell-mediated anti-myeloma immunity by increasing cytotoxic T helper cells and depleting CD38+ immunoregulatory cells, thereby potentiating teclistamab's activity. | Drug | Treatment Group |
Primary outcome
1-Year Progression-Free Survival (PFS) Rate
Time frame: From the start of treatment to 1 year, or until disease progression or death, whichever occurs first
The percentage of participants who are alive and free from disease progression at 1 year after initiation of Tec-Dara treatment. Progression is defined according to IMWG criteria, including increase in serum M protein, urine M protein, or serum free light chain; development of new bone lesions or soft tissue plasmacytomas; or hypercalcemia.
9 secondary outcomes
Hematologic Complete Response (Heme-CR) rate
Time frame: Up to 24 cycles (approximately 2 years)
Very Good Partial Response or Better (≥VGPR) Rate
Time frame: Up to 24 cycles (approximately 2 years)
Minimal Residual Disease (MRD) Negativity Rate
Time frame: 6 months and 12 months, and up to 24 cycles (approximately 2 years)
Organ Response Rate
Time frame: Up to 24 cycles (approximately 2 years)
Time to First Response
Time frame: Up to 24 cycles (approximately 2 years)
Duration of Response
Time frame: Up to 3 years from study start
Median Progression-Free Survival
Time frame: Up to 3 years from study start
Time to Next Treatment
Time frame: Up to 3 years from study start
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, up to 12 months after the end of study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peng Liu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab in people with Multiple Myeloma and AL Amyloidosis, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Liu (+86-021-64041990, liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Progression-Free Survival (PFS) Rate (time frame: From the start of treatment to 1 year, or until disease progression or death, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.