Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT04895917
Phase
PHASE2
Status
Terminated

Conditions

  • AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • daratumumab and pomalidomide — DRUG
    Patient eligible to enter the study will receive 6 cycles of 28 days of subcutaneous Daratumumab (1800 mg SC) and oral pomalidomide 4 mg from day 1 to day 21. During cycle 1 and 2, Daratumumab will be administered weekly at days 1, 8, 15, and 22 then from cycle 3 to 6, Daratumumab will be administered every other week at days 1 and 15.

Study Details

This study aims at establishing a new powerful combination of daratumumab and pomalidomide as rescue treatment for patients with R/R AL amyloidosis.

Key Dates

Start date
Jun 23, 2021
Status verified
Feb 2025
Primary completion
Dec 18, 2024
Completion
Jan 15, 2025

Study Design

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

Arms

  • Experimental: Pomalidomide and daratumumab

Primary Outcome Measure

Rate of good quality (i.e. CR+VGPR) hematologic response. [ Time Frame: 6 months ]

Related Studies