NCT04895917

Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis

A Multi-center Open Label Phase II Study of Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Despite recent advance in understanding the biology of the amyloidogenic clone and despite the availability of different therapeutic options, there are still patients who fail to respond to fist line therapy and experience relapse after response to first line regimens. The toxicity profile of daratumumab resulted favorable in the setting of advanced AL amyloidosis patients with severe organ damage. Pomalidomide has proven to be effective as a single agent in R/R AL amyloidosis with a better safety profile over lenalidomide because of relevant renal toxicity of the latter drug in presence of nephrotic proteinuria. Daratumumab is a recently released mAb that has shown deep hematological responses in R/R multiple myeloma with a favorable toxicity. Up-to-date clinical data have further demonstrated the high efficacy of combination regimens including an ImiD/Daratumumab combination in R/R multiple myeloma reaching unprecedented results in terms of response rate, progression free survival (PFS) and minimal residual disease (MRD) negativity. On these bases, the present study aims to explore the doublet Daratumumab/pomalidomide in R/R AL amyloidosis. The goal of the study is to obtain rapid, durable and deep hematological responses with a low toxicity profile. The expectation is to attain a very favorable benefit/risk ratio from this combination as these patients should experience a low rate of treatment discontinuation, hospitalization due AEs and/or disease progression and/or organ failures.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	daratumumab and pomalidomide	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.

Timeline

• Start date: 2021-06-23
• Primary completion: 2024-12-18
• Completion: 2025-01-15
• First posted: 2021-05-20
• Last updated: 2025-02-20

Locations

3 sites across 1 country: Italy