Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease

• Status: Completed
• Trial end date: 2017-03-27
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, phase II, open label study will enroll patients with chronic cold agglutinin disorder. A single course of Bortezomib will be given at the dose of 1,3 mg/sqm iv on days 1, 4, 8, 11.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Agglutinins; Bortezomib; Cold agglutinins

Criteria

Inclusion Criteria:

• Patients with chronic cold agglutinin disorder requiring or with a hemoglobin concentration below 10g/L determined at least monthly during the two months before entering the trial;

• Failure of at least one previous treatment attempt;

• Hemoglobin level assessment;

• Presence of serum cold agglutinin (CA). If an overnight incubation is used for CA detection, a titer at 4°C of 64 or higher is required;

• Written informed consent.

Exclusion Criteria:

• Presence of a concomitant lymphoproliferative disorder requiring specific treatment for reasons other than cold agglutinin related hemolytic anemia;

• Preexisting peripheral neuropathy;

• Known hypersensitivity to Bortezomib;

• Non-cooperative behaviour or non-compliance;

• Psychiatric diseases or conditions that might impair the ability to give informed consent;

• Patients who are pregnant (women of childbearing potential must have a negative serum pregnancy test). Post-menopausal women must be amenorrhoic for at least 24 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.