Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis

Sponsor
University Hospital, Limoges
Study ID
NCT02816476
Phase
PHASE2
Status
Completed

Conditions

  • Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled to receive study treatment. Patients will receive treatment until either disease progression or toxicity has occurred with a maximum planned of six 28-day cycles. Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from cycle 3 through cycle 6. Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects, and to address underlying Amyloidosis, including blood product transfusions, antimicrobials, and (as appropriate) growth factors including granulocyte colony-stimulating factors for neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia

Key Dates

Start date
Sep 30, 2016
Status verified
Jul 2021
Primary completion
Oct 5, 2019
Completion
Oct 31, 2020

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Patient will receive Daratumumab every week for the first 2 cycles then every 2 weeks from cycle 3 through cycle 6.

Primary Outcome Measure

Overall Response Rate [ Time Frame: After 6 cycles treatment (6 months). ]

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