Amyloidosis; SystemicNCT06192979
Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
A study testing Daratumumab, Bortezomib and Dexamethasone in people with Amyloidosis; Systemic and AL Amyloidosis, run by Jin Lu, MD at 7 sites in China.
Trial summary
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyloidosis; Systemic, AL Amyloidosis
- What is being tested?
- Daratumumab, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesChina
- Study dates
- 5 Jan 2024to 31 Mar 2027
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of systemic AL amyloidosis;
- Daratumumab, bortezomib, dexamethasone used in 1st line treatment;
- Life expectancy greater than 12 weeks;
- HGB ≥70g/L;
- Blood oxygen saturation >90%;
- Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
- Informed consent explained to, understood by and signed by the patient.
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
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yang Liu, +8613716926210, pkuphliuyang@bjmu.edu.cn
Jin Lu
- Recruiting
Capital Medical University Affiliated Fuxing Hospital
Beijing, Beijing Municipality, 100045
Liru Wang, M.D., 86-18618238652, wanglirumail@126.com
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 101118
Yini Wang, M.D., 86-139 0108 6559, catenny@hotmail.com
- Recruiting
Chinese PLA Eastern Theater General Hospital
Nanjing, Jiangsu, 210000
Xianghua Huang, M.D., 86-13770648824, 13770648824@163.com
- Recruiting
Qilu Hospital of Shandong University (QingDao)
Qingdao, Shandong, 266000
Zhao Li, M.D., 86-18561812670, lizhaom1979@163.com
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Yuping Zhong, 86-13501098223, zhongyp3352@126.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061
Huasheng Liu, M.D., 86-18991232963, Lhs681995@126.com
About this study
Official title: Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.
Read the detailed description
The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.
- Conditions
- Amyloidosis; Systemic, AL Amyloidosis
- Being tested
- Daratumumab, Bortezomib, Dexamethasone, Venetoclax
- Keywords
- t(11;14), Rapid Response, 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.
DaratumumabDrug
Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.
Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.
BortezomibDrug
All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.
DexamethasoneDrug
All patients received 20-40 mg oral or intravenous dexamethasone
VenetoclaxDrug
All patients received venetoclax 400mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Response Group | Other | Daratumumab, bortezomib, dexamethasone Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Dexamethasone |
| Non-Rapid Response Group | Other | Daratumumab, venetoclax, dexamethasone Receives: Drug: Daratumumab; Drug: Dexamethasone; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall CHR rate at 6 months
Overall complete hematologic response rate at 6 months
Measured: Overall CHR rate at 6 months
Secondary outcomes (7)
Cardiac response at 6 months
Cardiac response at 6 months
Measured: Cardiac response at 6 months
Renal response at 6 months
Renal response at 6 months
Measured: Renal response at 6 months
Hepatic response at 6 months
Hepatic response at 6 months
Measured: Hepatic response at 6 months
Estimated 2-year PFS
Estimated 2-year progression free survival
Measured: Estimated 2-year PFS
Estimated 2-year OS
Estimated 2-year overall survival
Measured: Estimated 2-year overall survival
MRD status at 6 months
Minimal residual disease status at 6 months
Measured: MRD status at 6 months
TRAEs
treatment-related adverse events up to 6 months
Measured: TRAEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start5 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis; SystemicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Lu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Jin Lu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192979
- Sponsor's protocol ID
- 2023PHB319-001
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No