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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

NCT06455748 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-12

No results posted yet for this study

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.

Conditions

  • Amyloid Light-chain Amyloidosis

Interventions

DRUG

Daratumumab/daratumumab and hyaluronidase-fihj

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.

DRUG

Pomalidomide

Pomalidomide: pom 2-4mg PO day (D) 1-21/28 (adjust dose for renal function).

DRUG

Dexamethasone

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.

Sponsors & Collaborators

  • Yongyong MA

    lead OTHER

Principal Investigators

  • Yongyong Ma, MD · First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-01-01
Completion
2025-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455748 on ClinicalTrials.gov