A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosis

Phase 1

• Conditions: AL Amyloidosis; MedDRA version: 16.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021445-42-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-27
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy,
• Age 18 -70 years inclusive at the time of signing the informed consent form,
• Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC> 50 mg/L,
• Life expectancy > 3 months,
• WHO performance status 0-2,
• NYHA 1-2,
• Negative pregnancy test at inclusion for women of childbearing potential,
• Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Multiple Myeloma stage II and III (Durie and Salmon),
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
• Previous treatment for plasma cell dyscrasia
• Pregnant or breast feeding females.
• Presence of other active malignancy or a history of active malignancy during the past 5 years, with the exception of nonmelanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits,
• Hypersensitivity to boron or mannitol,
• Uncontrolled infection,
• Symptomatic othostatic hypotension defined as a decrease in systolic blood pressure on standing of >20mmHg combined with symptoms like dizziness, cerebral and/or cardial ischemia,
• Symptomatic effusions, defined as pleural effusion or ascites needing drainage therapy,
•NT pro BNP level > 5000 pg/ml and Troponin T> 0.06 microgram/l (not high senstitivity assay) or NT proBNP level > 5000 pg/ml and Troponin I > 2 times ULN
• Positive for HIV or infectious hepatitis, B or C,
• Bilirubin > 2x upper limit of normal,
• Creatinin clearance < 30 ml/min (after rehydration),
• Absolute neutrophil count < 1.0 × 109/L,
• NCI CTCAE grade peripheral sensory neuropathy > grade 2,
• NCI CTCAE grade peripheral sensory neuropathy > grade 1 in the presence of neuropathic pain,
•NCI CTCAE grade peripheral motor neuropathy > grade 2
• Concurrent diagnosis of B-cel NHL or B-CLL,
• Previous organ transplantation.
• Unwilling or unable to use adeaquate contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified