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

Sponsor
Yongyong MA
Study ID
NCT06455748
Status
Recruiting
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Conditions

  • Amyloid Light-chain Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab/daratumumab and hyaluronidase-fihj — DRUG
    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.
  • Pomalidomide — DRUG
    Pomalidomide: pom 2-4mg PO day (D) 1-21/28 (adjust dose for renal function).
  • Dexamethasone — DRUG
    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 Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jun 2024
Primary completion
Jan 1, 2025
Completion
Mar 1, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd)
    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.

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. ]

Central Contacts

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