Amyloid Light-chain AmyloidosisNCT06455748
Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study
A study testing Daratumumab/daratumumab and hyaluronidase-fihj, Pomalidomide and Dexamethasone in people with Amyloid Light-chain Amyloidosis, run by Yongyong MA at 1 site in China.
Trial summary
This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyloid Light-chain Amyloidosis
- What is being tested?
- Daratumumab/daratumumab and hyaluronidase-fihj, Pomalidomide and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;
- ECOG PS score 0-2 points;
- Measurable disease: The difference between affected and unaffected FLC is>20 mg/L, and the serum immunoglobulin kappa λ FLC ratio is abnormal;
- Having sufficient organ and bone marrow function, defined as follows:
- Blood routine: Absolute neutrophil count ≥ 1.0 x 10 ^ 9/L, platelet count ≥ 50 x 10 ^ 9/L;
- Blood biochemistry and electrolytes: ALT and AST both ≤ 3 times the upper limit of normal, total bilirubin ≤ 1.5 times the upper limit of normal, creatinine clearance rate ≥ 30 mL/min, serum corrected calcium ≤ 14.0 mg/dL (≤ 3.5 mmol/L) or free ion calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);
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- Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 3 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; In addition, if the subject misses their menstrual period or experiences abnormal menstrual bleeding, the researcher can conduct a pregnancy trial at any time during the study period;
- Men must agree to use contraceptive measures during the study period and within 3 months after the end of the study period;
- The patient agrees to participate in the clinical trial and signs an informed consent form.
Who cannot join
- Non AL amyloidosis;
- Known to be allergic, hypersensitive or intolerant to monoclonal antibodies or human derived proteins, daretozumab or its excipients, or known to be allergic to mammalian derivatives;
- Female patients who have tested positive for lactation or serum pregnancy test during the screening period;
- Received ASCT or had graft-versus-host disease in the past 12 months;
- Suffering from moderate or severe persistent asthma within 2 years prior to enrollment, or having uncontrolled asthma at the time of enrollment;
- Evidence of having other malignant tumors within the 3 years prior to enrollment or having been previously diagnosed with another malignant tumor with any residual lesions;
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- Suffering from chronic obstructive pulmonary disease (COPD), the forced expiratory volume (FEV1) in one second is less than 50% of the normal expected value;
- Clinically significant heart disease, including:
- Start studying myocardial infarction or unstable or uncontrollable conditions within 6 months prior to treatment (such as unstable angina, congestive heart failure, New York Heart Association (NYHA) III-IV);
- Arrhythmias (NCI CTCAE V5.0 standard ≥ grade 3) or clinically significant electrocardiogram (ECG) abnormalities;
- The electrocardiogram shows a baseline corrected QT (QTc) interval>470 ms;
- Active infections, including but not limited to HAV, HBV, HCV, HIV;
- Plasma cell leukemia (circulating plasma cells>2.0 × 10 ^ 9/L) or Waldenstrom macroglobulinemia (WM) or POEMS syndrome (multiple neuropathies, organ enlargement, endocrine disorders, monoclonal plasma cell disease, and skin changes);
- Peripheral neuropathy or neuralgia of grade 2 or above (CTCAE 5.0 standard);
- Underwent major surgery within 14 days prior to enrollment, or did not fully recover from early surgery, or planned surgery during the study period or within 14 days after the last study drug treatment (note: does not include surgery under local anesthesia or kyphoplasty or vertebroplasty);
- According to the judgment of the investigator, there are concomitant diseases (such as active systemic infection, uncontrolled diabetes, acute diffuse invasive pulmonary disease, neurological or mental disease, etc.) or any other conditions that may confuse the research results or affect the completion of the study;
- Individuals who are receiving any other experimental drugs or experimental medical devices;
- The researchers believe that the patient has other circumstances that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yongyong Ma, MD, +86-13566281793, mayy@wmu.edu.cn
Yongyong Ma, MD
About this study
This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.
Read the detailed description
Primary objective:
Hematologic overall remission rate (ORR) as defined by the criteria in the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light Chain Amyloidosis, 2021 edition.
Secondary objective:
- organ remission rate as defined by the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light-Chain Amyloidosis 2021 Edition, hematologic complete remission (CR) rate, very good partial remission (VGPR) rate, progression free survival (PFS), overall survival (OS), and negative rate of microscopic residual disease (MRD).
- safety of combination therapy regimens.
Exploratory purpose:
EORTC QLQ-C30.
- Conditions
- Amyloid Light-chain Amyloidosis
- Being tested
- Daratumumab/daratumumab and hyaluronidase-fihj, Pomalidomide, Dexamethasone
- 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.
Daratumumab/daratumumab and hyaluronidase-fihjDrug
Also called Dara
Daratumumab/daratumumab and hyaluronidase-fihj: Dara SC 1800mg subcutaneous (IH) or Dara 16mg/kg intravenously (IV) administered weekly (qwk) x 4 every 2 weeks X 3 doses per month starting C7.
PomalidomideDrug
Also called pom
Pomalidomide: pom 2-4mg PO day (D) 1-21/28 (adjust dose for renal function).
DexamethasoneDrug
Also called dex
Dexamethasone: dex C1: 20mg IV D1/8, 20mg PO D2/9 and 40mg PO C1D15 weekly up to C6, then 20mg IV monthly starting C7D1 and 20mg PO D8, 15, 22.
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd) | Experimental | Observed patients meeting the screening criteria were treated with Daratumumab/daratumumab and hyaluronidase-fihj + pomalidomide + dexamethasone regimen as appropriate.
Combined regimen of the above until disease progression or up to 2 years. Receives: Drug: Daratumumab/daratumumab and hyaluronidase-fihj; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic Overall Remission Rate (ORR)
ORR was defined as the proportion of subjects who achieved partial remission (PR) or better partial remission (VGPR) and complete response (CR) by Guideline 2021 Edition criteria.
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Secondary outcomes (7)
Hematologic complete remission (CR) rate
Negative blood/urine immunofixation electrophoresis and normal serum free light chain levels and ratios.
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Very good partial remission (VGPR) rate
dFLC decreased to <40 mg/L
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Overall survival (OS)
OS: defined as the time from the start of the subject's randomization enrollment until death or final follow-up (time lost to follow-up).
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Progression free survival （PFS）
PFS was defined as the period from the subject's randomization to enrollment to the date of the first documented disease progression (PD) (rated according to IMWG criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Negative rate of microscopic residual disease (MRD)
MRD level: MRD was detected using second-generation sequencing (NGS) for bone marrow MRD levels. MRD negative rate: MRD is only evaluated in patients who achieve CR or better.
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Time to response (TTR)
TTR: defined as the period from randomization of subjects to the date of first recorded disease remission.
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Duration of response (DOR)
DOR: defined as the date from the first recording of treatment response to the first recording of disease progression or the date of death from any cause.
Measured: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Mar 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid Light-chain 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongyong MA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongyong MA, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Yongyong Ma, MD, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455748
- Sponsor's protocol ID
- Poma-DD-AL-01
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study
- ClinicalTrials.gov ID
- NCT06455748
- Acronym / sponsor ID
- Poma-DD-AL-01
- Conditions
- Amyloid Light-chain Amyloidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yongyong MAUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 12 Jun 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 and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.
Detailed description
Primary objective:
Hematologic overall remission rate (ORR) as defined by the criteria in the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light Chain Amyloidosis, 2021 edition.
Secondary objective:
- organ remission rate as defined by the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light-Chain Amyloidosis 2021 Edition, hematologic complete remission (CR) rate, very good partial remission (VGPR) rate, progression free survival (PFS), overall survival (OS), and negative rate of microscopic residual disease (MRD).
- safety of combination therapy regimens.
Exploratory purpose:
EORTC QLQ-C30.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd) | Experimental | Drug: Daratumumab/daratumumab and hyaluronidase-fihj, Drug: Pomalidomide, Drug: DexamethasoneObserved patients meeting the screening criteria were treated with Daratumumab/daratumumab and hyaluronidase-fihj + pomalidomide + dexamethasone regimen as appropriate. Combined regimen of the above until disease progression or up to 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;
- ECOG PS score 0-2 points;
- Measurable disease: The difference between affected and unaffected FLC is>20 mg/L, and the serum immunoglobulin kappa λ FLC ratio is abnormal;
- Having sufficient organ and bone marrow function, defined as follows:
- Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 3 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; In addition, if the subject misses their menstrual period or experiences abnormal menstrual bleeding, the researcher can conduct a pregnancy trial at any time during the study period;
Key exclusion criteria (18 listed)
- Non AL amyloidosis;
- Known to be allergic, hypersensitive or intolerant to monoclonal antibodies or human derived proteins, daretozumab or its excipients, or known to be allergic to mammalian derivatives;
- Female patients who have tested positive for lactation or serum pregnancy test during the screening period;
- Received ASCT or had graft-versus-host disease in the past 12 months;
- Suffering from moderate or severe persistent asthma within 2 years prior to enrollment, or having uncontrolled asthma at the time of enrollment;
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 |
|---|---|---|
| Daratumumab/daratumumab and hyaluronidase-fihjAlso: DaraDaratumumab/daratumumab and hyaluronidase-fihj: Dara SC 1800mg subcutaneous (IH) or Dara 16mg/kg intravenously (IV) administered weekly (qwk) x 4 every 2 weeks X 3 doses per month starting C7. | Drug | Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd) |
| PomalidomideAlso: pomPomalidomide: pom 2-4mg PO day (D) 1-21/28 (adjust dose for renal function). | Drug | Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd) |
| DexamethasoneAlso: dexDexamethasone: dex C1: 20mg IV D1/8, 20mg PO D2/9 and 40mg PO C1D15 weekly up to C6, then 20mg IV monthly starting C7D1 and 20mg PO D8, 15, 22. | Drug | Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd) |
Primary outcome
Hematologic Overall Remission Rate (ORR)
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
ORR was defined as the proportion of subjects who achieved partial remission (PR) or better partial remission (VGPR) and complete response (CR) by Guideline 2021 Edition criteria.
7 secondary outcomes
Hematologic complete remission (CR) rate
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Very good partial remission (VGPR) rate
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Overall survival (OS)
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Progression free survival （PFS）
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Negative rate of microscopic residual disease (MRD)
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Time to response (TTR)
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Duration of response (DOR)
Time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- 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. This study is not recruiting at the moment.
Yongyong Ma, MD principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daratumumab/daratumumab and hyaluronidase-fihj, Pomalidomide and Dexamethasone in people with Amyloid Light-chain Amyloidosis, run by Yongyong MA 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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 12 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongyong Ma, MD (+86-13566281793, mayy@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic Overall Remission Rate (ORR) (time frame: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.). 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 12 Jun 2024.