Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

NCT06192979 | Recruiting

• 1 other identifier: 2023PHB319-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Amyloidosis; Systemic; AL Amyloidosis

Keywords

t(11;14); Rapid Response; AL amyloidosis

Outcome Measures

Primary Outcomes (1)

• Overall CHR rate at 6 months

  Overall complete hematologic response rate at 6 months

  Overall CHR rate at 6 months

Secondary Outcomes (7)

• Cardiac response at 6 months

  Cardiac response at 6 months

• Renal response at 6 months

  Renal response at 6 months

• Hepatic response at 6 months

  Hepatic response at 6 months

• Estimated 2-year PFS

  Estimated 2-year PFS

• Estimated 2-year OS

  Estimated 2-year overall survival

Study Arms (2)

Rapid Response Group

OTHER

Daratumumab, bortezomib, dexamethasone

Drug: Daratumumab; Drug: Bortezomib; Drug: Dexamethasone

Non-Rapid Response Group

OTHER

Daratumumab, venetoclax, dexamethasone

Drug: Daratumumab; Drug: Dexamethasone; Drug: Venetoclax

Interventions

Daratumumab DRUG

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.

Non-Rapid Response Group; Rapid Response Group

Bortezomib DRUG

All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.

Rapid Response Group

Dexamethasone DRUG

All patients received 20-40 mg oral or intravenous dexamethasone

Non-Rapid Response Group; Rapid Response Group

Venetoclax DRUG

All patients received venetoclax 400mg daily.

Non-Rapid Response Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Lu, MD: lead

Study Sites (6)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Capital Medical University Affiliated Fuxing Hospital

Beijing, Beijing Municipality, 100045, China

RECRUITING

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 101118, China

RECRUITING

Chinese PLA Eastern Theater General Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Interventions

daratumumab; Bortezomib; Dexamethasone; venetoclax

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jin Lu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Lu

CONTACT

+8613311491805; jin1lu@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 5, 2024
• Study Start: January 5, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (6)