Overview

Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis

Status:
Unknown status
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
All
Summary
To prove the organ-reversing potential of thalidomide for amyloidosis with cardiac involvement
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Collaborator:
CW pharmaceutical company
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Thalidomide
Criteria
Inclusion Criteria:

1. Age : more than 18 years old

2. Cardiac amyloidosis (both AL or AH type) patient who meet both (A and B) of the
following criteria A. Cardiac involvement: meet one of the following criteria

- Echocardiography: mean wall thickness >12 mm, and no other cardiac cause

- NTproBNP >332 ng/l in the absence of renal failure

- Evidence of cardiac amyloidosis in cardiac MRI B. Treatment history: No history
of exposure to thalidomide

3. ECOG(Eastern Cooperative Oncology Group) performance status ≤ 3

4. Tolerable major organ function determined by laboratory examination i. Serum
creatinine ≤ 3.0 mg/dl ii. Absolute neutrophil count ≥ 1000/μl iii. Platelet ≥ 75000/
μl iv. Hemoglobin ≥ 8.0 mg/dl v. Bilirubin < 2 times or Alkaline phosphate < 4 times
upper limit of normal

5. Expected survival > 3 months

6. Female participants of child-bearing potential must have a negative pregnancy test
prior to treatment and agree to use dual methods of contraception for the duration of
the study and for 30 days following completion of study. Male participants must also
agree to use a barrier method of contraception for the duration of the study and for
30 days following completion of study if sexually active with a female of
child-bearing potential.

Exclusion Criteria:

1. Amyloidosis without cardiac involvement

2. Patients who are planning to receive autologous stem cell transplantation

3. Patients who received autologous stem cell transplantation, remained in hematologic
complete response

4. Pregnant, lactating or unwilling to use adequate contraception

5. Systemic infection unless specific anti-infective therapy is employed

6. Known allergies to thalidomide

7. Previous experimental agents or approved anti-tumor treatment within 1 months before
the date of registration