Light Chain (AL) AmyloidosisNCT06376214
Daratumumab for Patients With Light Chain Amyloidosis
A study testing Dratumumab / Hyaluronidase Injection [Darzalex Faspro], Pomalidomide 4 MG and autologous stem cell transplantation (ASCT) in people with Light Chain (AL) Amyloidosis, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Light Chain (AL) Amyloidosis
- What is being tested?
- Dratumumab / Hyaluronidase Injection [Darzalex Faspro], Pomalidomide 4 MG and autologous stem cell transplantation (ASCT)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be aged ≥18 and ≤75 years;
- Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
- In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP>8500ng/L and cTnT>0.035μg/L or cTnI>0.01g/L;
- Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
- Expected survival ≥ 12 weeks;
- ECOG performance status≤ 2;
- Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of <1% per year.
Who cannot join
- eGFR< 30ml/min/1.73m2;
- Combined multiple myeloma;
- Acute or chronic infection requiring treatment within 30 days prior to baseline;
- Pregnant or breastfeeding women.
- Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
- Other conditions deemed by the researcher as unsuitable for enrollment.
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
National Clinical Research Center for Kidney Diseases, Jinling Hospital
Nanjing, Jiangsu, 210016
Xianghua Huang, MD, 02580862351, hxhszb@163.com
About this study
Official title: Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial
This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.
Read the detailed description
This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen (group A) and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen (group B) , and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment (group C). Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression. Group C were given Daratumumab (16mg/kg), dexamethasone (40mg) and pomalidomide. The usage of Daratumumab and dexamethasone is the same as group A and B. Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. The dose of pomalidomide is adjusted based on the patient's renal function and ECOG score.
- Conditions
- Light Chain (AL) Amyloidosis
- Being tested
- Dratumumab / Hyaluronidase Injection [Darzalex Faspro], Pomalidomide 4 MG, autologous stem cell transplantation (ASCT)
- Keywords
- light chain amyloidosis, daratumumab, stem cell transplantation
- Medical subject headings
- Amyloidosis, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dratumumab / Hyaluronidase Injection [Darzalex Faspro]Drug
Also called DARA
Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.
Pomalidomide 4 MGDrug
Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.
autologous stem cell transplantation (ASCT)Procedure or surgery
The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2
.
| Study group | Role | What they receive |
|---|---|---|
| long-term daratumumab treatment group (group A) | Active comparator | The patient will receive the standard protocol of daratumumab combined with dexamethasone treatment, once a week for the first two months, once every two weeks for four months, and then once a month for 18 months. Receives: Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro] |
| daratumumab combine with ASCT treatment group (group B) | Experimental | This group of patients will first receive two courses of treatment with the standard protocol of daratumumab combined with dexamethasone. Subsequent patients will receive ASCT treatment, and patients who achieve VGPR or CR after transplantation treatment will be followed up for observation Receives: Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro]; Procedure: autologous stem cell transplantation (ASCT) |
| Daratumumab and Dexamethasone combined with pomalidomide (DPD) (group C) | Experimental | newly diagnosed stage IIIb AL amyloidosis patients will received Daratumumab (16mg/kg), dexamethasone (40mg) and pomalidomide. The usage of Daratumumab and dexamethasone is the same as group A. Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. The dose of pomalidomide is adjusted based on the patient's renal function and ECOG score. Receives: Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro]; Drug: Pomalidomide 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological complete response rate
the 6 months overall hematologic complete response rate after treatment.
Measured: 6 months
Organ response rate
the 1-year organ response rate after treatment
Measured: 1 year
Secondary outcomes (3)
Time to Next Treatment
Number of months from study drug initiation to starting another treatment
Measured: 3 years
Progression-free survival
the 3 years progression-free survival after treatment
Measured: 3 years
Overall survival
the 5 years overall survival after treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (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 Light Chain (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Hong Liu, MD, Nanjing University School of Medicine
- Investigators
- Xianghua Huang, MD, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376214
- Sponsor's protocol ID
- 2024-02
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial
- ClinicalTrials.gov ID
- NCT06376214
- Acronym / sponsor ID
- 2024-02
- Conditions
- Light Chain (AL) Amyloidosis
- Keywords
- light chain amyloidosis, daratumumab, stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 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.
This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.
Detailed description
This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen (group A) and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen (group B) , and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment (group C). Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression. Group C were given Daratumumab (16mg/kg), dexamethasone (40mg) and pomalidomide. The usage of Daratumumab and dexamethasone is the same as group A and B. Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. The dose of pomalidomide is adjusted based on the patient's renal function and ECOG score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| long-term daratumumab treatment group (group A) | Active comparator | Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro]The patient will receive the standard protocol of daratumumab combined with dexamethasone treatment, once a week for the first two months, once every two weeks for four months, and then once a month for 18 months. |
| daratumumab combine with ASCT treatment group (group B) | Experimental | Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro], Procedure: autologous stem cell transplantation (ASCT)This group of patients will first receive two courses of treatment with the standard protocol of daratumumab combined with dexamethasone. Subsequent patients will receive ASCT treatment, and patients who achieve VGPR or CR after transplantation treatment will be followed up for observation |
| Daratumumab and Dexamethasone combined with pomalidomide (DPD) (group C) | Experimental | Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro], Drug: Pomalidomide 4 MGnewly diagnosed stage IIIb AL amyloidosis patients will received Daratumumab (16mg/kg), dexamethasone (40mg) and pomalidomide. The usage of Daratumumab and dexamethasone is the same as group A. Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. The dose of pomalidomide is adjusted based on the patient's renal function and ECOG score. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be aged ≥18 and ≤75 years;
- Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
- In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP>8500ng/L and cTnT>0.035μg/L or cTnI>0.01g/L;
- Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
- Expected survival ≥ 12 weeks;
Key exclusion criteria (6 listed)
- eGFR< 30ml/min/1.73m2;
- Combined multiple myeloma;
- Acute or chronic infection requiring treatment within 30 days prior to baseline;
- Pregnant or breastfeeding women.
- Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
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 |
|---|---|---|
| Dratumumab / Hyaluronidase Injection [Darzalex Faspro]Also: DARADaratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion. | Drug | Daratumumab and Dexamethasone combined with pomalidomide (DPD) (group C), daratumumab combine with ASCT treatment group (group B), long-term daratumumab treatment group (group A) |
| Pomalidomide 4 MGPatients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. | Drug | Daratumumab and Dexamethasone combined with pomalidomide (DPD) (group C) |
| autologous stem cell transplantation (ASCT)The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 . | Procedure or surgery | daratumumab combine with ASCT treatment group (group B) |
Primary outcome
Hematological complete response rate
Time frame: 6 months
the 6 months overall hematologic complete response rate after treatment.
Organ response rate
Time frame: 1 year
the 1-year organ response rate after treatment
3 secondary outcomes
Time to Next Treatment
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 5 years
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 19 Apr 2024.
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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.
Xianghua Huang, MD principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dratumumab / Hyaluronidase Injection [Darzalex Faspro], Pomalidomide 4 MG and autologous stem cell transplantation (ASCT) in people with Light Chain (AL) Amyloidosis, run by Nanjing University School of Medicine 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 7 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 19 Apr 2024. 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.
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 Xianghua Huang, MD (02580862351, hxhszb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematological complete response rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 19 Apr 2024.