Trial 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
NCT ID:
NCT06455748
Condition:
Amyloid Light-chain Amyloidosis
Conditions: Official terms:
Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Dexamethasone
Daratumumab
Pomalidomide
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Daratumumab/daratumumab and hyaluronidase-fihj
Description:
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.
Arm group label:
Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd)
Other name:
Dara
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
Pomalidomide: pom 2-4mg PO day (D) 1-21/28 (adjust dose for renal function).
Arm group label:
Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd)
Other name:
pom
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
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.
Arm group label:
Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd)
Other name:
dex
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.
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:
1. 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).
2. safety of combination therapy regimens.
Exploratory purpose:
EORTC QLQ-C30.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;
2. ECOG PS score 0-2 points;
3. Measurable disease: The difference between affected and unaffected FLC is>20 mg/L,
and the serum immunoglobulin kappa λ FLC ratio is abnormal;
4. Having sufficient organ and bone marrow function, defined as follows:
1. Blood routine: Absolute neutrophil count ≥ 1.0 x 10 ^ 9/L, platelet count ≥ 50
x 10 ^ 9/L;
2. 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);
5. 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;
6. Men must agree to use contraceptive measures during the study period and within 3
months after the end of the study period;
7. The patient agrees to participate in the clinical trial and signs an informed
consent form.
Exclusion Criteria:
1. Non AL amyloidosis;
2. 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;
3. Female patients who have tested positive for lactation or serum pregnancy test
during the screening period;
4. Received ASCT or had graft-versus-host disease in the past 12 months;
5. Suffering from moderate or severe persistent asthma within 2 years prior to
enrollment, or having uncontrolled asthma at the time of enrollment;
6. 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;
7. Suffering from chronic obstructive pulmonary disease (COPD), the forced expiratory
volume (FEV1) in one second is less than 50% of the normal expected value;
8. Clinically significant heart disease, including:
1. 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);
2. Arrhythmias (NCI CTCAE V5.0 standard ≥ grade 3) or clinically significant
electrocardiogram (ECG) abnormalities;
3. The electrocardiogram shows a baseline corrected QT (QTc) interval>470 ms;
9. Active infections, including but not limited to HAV, HBV, HCV, HIV;
10. 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);
11. Peripheral neuropathy or neuralgia of grade 2 or above (CTCAE 5.0 standard);
12. 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);
13. 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;
14. Individuals who are receiving any other experimental drugs or experimental medical
devices;
15. The researchers believe that the patient has other circumstances that are not
suitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongyong Ma, MD
Phone:
+86-13566281793
Email:
mayy@wmu.edu.cn
Investigator:
Last name:
Yongyong Ma, MD
Email:
Principal Investigator
Investigator:
Last name:
Songfu Jiang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Shujuan Zhou, MD
Email:
Sub-Investigator
Investigator:
Last name:
Honglan Qian, MD
Email:
Sub-Investigator
Start date:
March 1, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Yongyong MA
Agency class:
Other
Source:
First Affiliated Hospital of Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455748
