Systemic AL AmyloidosisNCT06627309
Rapid dFLC Response Predict CHR in AL Amyloidosis
An observational study of Systemic AL Amyloidosis, run by Peking University People's Hospital at 8 sites in China.
Trial summary
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic AL Amyloidosis
- What is being tested?
- Dara IV, Bortezomib (drug) and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 50 participants
- Where
- 8 sitesChina
- Study dates
- 26 Oct 2024to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Systemic AL amyloidosis patients with evaluable hematologic parameter
Who may be able to join
- Diagnosis of systemic AL amyloidosis;
- Daratumumab, bortezomib, dexamethasone used in treatment;
- Informed consent explained to, understood by and signed by the patient;
- dFLC ≥ 50 mg/L;
Who cannot join
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma;
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patients with HIV infection or syphilis infection;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Recruiting
Fuxing Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100045
Liru Wang, 86-18618238625, wanglirumail@126.com
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 101118
Yini Wang, M.D., 86-139 0108 6559, catenny@hotmail.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Fudeng Zhou, 86-135 0116 2527, zhoufude1801@vip.sina.com
- Recruiting
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Yanqiu Zhao, 86-17745672811, 17745672811@163.com
- Recruiting
Chinese PLA Eastern Theater General Hospital
Nanjing, Jiangsu
Xianghua Huang, M.D., 86-13770648824, 13770648824@163.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Aijun Liao, 86-18940259833, liaoaijun@sina.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an
Huasheng Liu, 86-18991232963, Lhs681995@126.com
About this study
Official title: Rapid dFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated With Daratumumab-based Regimen
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.
- Conditions
- Systemic AL Amyloidosis
- Being tested
- Dara IV, Bortezomib (drug), Dexamethasone, Cyclophosphamide (CTX), Dara SC
- Keywords
- rapid dFLC response, daratumumab, systemic al amyloidosis
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dara IVDrug
The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.
Bortezomib (drug)Drug
Bortezomib is administered subcutaneously. The dosage range from 0.7 to 1.3 mg/m2 on days 1, 8, 15, and 22 of each cycle, for a maximum of 6 cycles
DexamethasoneDrug
Dexamethasone is administered intravenously at a dose of 40 mg weekly for each cycle, for a maximum of 6 cycles. For patients over 70 years of age or with severe edema, heart failure, or uncontrolled diabetes mellitus, dexamethasone can be administered at a dose of 10-20 mg per week.
Cyclophosphamide (CTX)Drug
Some patients may receive cyclophosphamide orally or intravenously at a dosage of 300 mg/m2 weekly.
Dara SCDrug
The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All patients in this cohort receive daratumumab, bortezomib and dexamethasone as treatment.
All patients receive additional sFLC examination in C1D7, C1D14. Receives: Drug: Dara IV; Drug: Bortezomib (drug); Drug: Dexamethasone; Drug: Cyclophosphamide (CTX); Drug: Dara SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete hematologic response
Measured: 6 months
Secondary outcomes (6)
Overall hematologic response
Measured: 6 months
At least one organ response
Measured: 12 months
Minimal residual disease
Bone marrow miminal residual disease
Measured: 6 months, 12 months
TTNT
Time to next treatment
Measured: 12 months
MOD-EFS
Major Organ Deterioration Event-Free Survival (MOD-EFS) is defined as the time from the beginning of treatment to hematologic progression, clinical manifestation of end-stage cardiac or renal disease, initiation of subsequent other anti-plasma cell therapy, or death, whichever occur first
Measured: 12 months
MOD-PFS
Major organ deterioration progression-free survival (MOD-PFS) is defined as the time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occur first
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start26 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic AL AmyloidosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627309
- Sponsor's protocol ID
- 2023PHB319-001-02
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid dFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated With Daratumumab-based Regimen
- ClinicalTrials.gov ID
- NCT06627309
- Acronym / sponsor ID
- 2023PHB319-001-02
- Conditions
- Systemic AL Amyloidosis
- Keywords
- rapid dFLC response, daratumumab, systemic al amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Oct 2024 (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.
Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Dara IV, Drug: Bortezomib (drug), Drug: Dexamethasone, Drug: Cyclophosphamide (CTX), Drug: Dara SCAll patients in this cohort receive daratumumab, bortezomib and dexamethasone as treatment. All patients receive additional sFLC examination in C1D7, C1D14. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic AL amyloidosis patients with evaluable hematologic parameter
Key inclusion criteria (4 listed)
- Diagnosis of systemic AL amyloidosis;
- Daratumumab, bortezomib, dexamethasone used in treatment;
- Informed consent explained to, understood by and signed by the patient;
- dFLC ≥ 50 mg/L;
Key exclusion criteria (6 listed)
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma;
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patients with HIV infection or syphilis infection;
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 |
|---|---|---|
| Dara IVThe treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy. | Drug | Group 1 |
| Bortezomib (drug)Bortezomib is administered subcutaneously. The dosage range from 0.7 to 1.3 mg/m2 on days 1, 8, 15, and 22 of each cycle, for a maximum of 6 cycles | Drug | Group 1 |
| DexamethasoneDexamethasone is administered intravenously at a dose of 40 mg weekly for each cycle, for a maximum of 6 cycles. For patients over 70 years of age or with severe edema, heart failure, or uncontrolled diabetes mellitus, dexamethasone can be administered at a dose of 10-20 mg per week. | Drug | Group 1 |
| Cyclophosphamide (CTX)Some patients may receive cyclophosphamide orally or intravenously at a dosage of 300 mg/m2 weekly. | Drug | Group 1 |
| Dara SCThe treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy. | Drug | Group 1 |
Primary outcome
Complete hematologic response
Time frame: 6 months
6 secondary outcomes
Overall hematologic response
Time frame: 6 months
At least one organ response
Time frame: 12 months
Minimal residual disease
Time frame: 6 months, 12 months
TTNT
Time frame: 12 months
MOD-EFS
Time frame: 12 months
MOD-PFS
Time frame: 12 months
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic AL Amyloidosis, run by Peking University People's Hospital at 8 sites 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 4 inclusion and 6 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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 Yang Liu, M.D. (+86-13716926210, pkuphliuyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete hematologic response (time frame: 6 months). 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 9 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.