Cardiac AL amyloidosis MedDRA version: 20.0 Level: PT Classification code 10007509 Term: Cardiac amyloidosis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: BASSADO - 100 MG COMPRESSE 10 COMPRESSE
Product Name: Doxiciclina
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: DOXICICLINA
CAS Number: 564-25-0
Current Sponsor code: N
Sponsors
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18. 2. newly-diagnosed AL amyloidosis. 3. Confirmed diagnoses of AL amyloidosis by the following: a) histochemical diagnoses of AL amyloidosis determined by polarizing light microscopy of green birefringent material in Congo red stained issue specimens OR characteristic electron microscopy appearance AND b) Confirmatory electron microscopy immunohistochemistry OR mass spectroscopy of AL amyloidosis. Confirmation of amyloid type can be omitted in patients with a clear-cut clinical evidence of AL amyloidosis (e.g. cardiac and renal involvement, soft tissue involvement) in the presence of a monoclonal component. 4. Cardiac involvement grade II/IIIa 5. Planned bortezomib-based therapy. 6. Total bilirubin 1.5 × url without any other liver function test abnormalities are still eligible. 7. Alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: 1. Non-AL amyloidosis. 2. Stage IIIb cardiac involvement 3. Previous treatment for AL amyloidosis. 4. Clinically overt multiple myeloma with lytic bone lesions. 5. Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject’s ability to safely receive treatment or complete study assessments. 6. Patients with uncontrolled infection or active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. 7. Known HIV positive. 8. Pregnant or nursing women. 9. Known hypersensitivity to doxycycline, bortezomib, boron, or mannitol. 10. Treatment with drugs potentially affecting doxycycline absorption. 11. Significant acute gastrointestinal symptoms. 12. Active peptic ulceration and/or esophageal reflux disease. 13. Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study. 14. Contraindication to bortezomib based therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of survival after 12 months;Secondary Objective: - safety, i.e. rate of severe (CTCAE v5.0) grade 3 or greater adverse events) - rate of infective adverse events of any grade - cardiac response at 2, 4, 6 and 12 months - hematologic response at 2, 4, 6 and 12 months - renal response at 2, 4, 6 and 12 months;Primary end point(s): Survival;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - safety, i.e. rate of severe (CTCAE v5.0) grade 3 or greater adverse events) - rate of infective adverse events of any grade - cardiac response at 2, 4, 6 and 12 months - hematologic response at 2, 4, 6 and 12 months - renal response at 2, 4, 6 and 12 months;Timepoint(s) of evaluation of this end point: 2, 4, 6 and 12 months | — |
Countries
Germany, Italy
Contacts
Public ContactCentro per lo studio e la cura dell
Fondazione IRCCS Policlinico San Matteo di Pavia
Outcome results
None listed