Daratumumab for Patients With Light Chain Amyloidosis

NCT06376214 | Recruiting

• 1 other identifier: 2024-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Light Chain (AL) Amyloidosis

Keywords

light chain amyloidosis; daratumumab; stem cell transplantation

Outcome Measures

Primary Outcomes (2)

• Hematological complete response rate

  the 6 months overall hematologic complete response rate after treatment.

  6 months

• Organ response rate

  the 1-year organ response rate after treatment

  1 year

Secondary Outcomes (3)

• Time to Next Treatment

  3 years

• Progression-free survival

  3 years

• Overall survival

  5 years

Study Arms (3)

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.

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

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.

Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro]; Drug: Pomalidomide 4 MG

Interventions

Dratumumab / Hyaluronidase Injection [Darzalex Faspro] DRUG

Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.

Also known as: DARA

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 MG DRUG

Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.

Daratumumab and Dexamethasone combined with pomalidomide (DPD) (group C)

autologous stem cell transplantation (ASCT) PROCEDURE

The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .

daratumumab combine with ASCT treatment group (group B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

National Clinical Research Center for Kidney Diseases, Jinling Hospital

Nanjing, Jiangsu, 210016, China

RECRUITING

MeSH Terms

Conditions

Amyloidosis; Immunoglobulin Light-chain Amyloidosis

Interventions

Hyaluronoglucosaminidase; pomalidomide

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Officials

• Xianghua Huang, MD

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianghua Huang, MD

CONTACT

02580862351; hxhszb@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 19, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)