Trial | NCT02966522  Report issue

Title

Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis
Frontline Thalidomide for Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of Lenalidomide

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
To prove the organ-reversing potential of thalidomide for amyloidosis with cardiac involvement
Considering that dismal prognosis of amyloidosis is attributable to organ dysfunction, primary aim of amyloidosis treatment should be an organ reversal. However, due to various reasons, not much is known about organ reversal in amyloidosis. Almost all of the clinical trials evaluated hematologic response in amyloidosis. Meanwhile, besides autologous stem cell transplantation with high-dose melphalan conditioning, hematologic response rate of various agents such as bortezomib, melphalan, thalidomide and lenalidomide are similar for amyloidosis. However, organ reversing potential of these agents is not known. If there is a difference in organ reversing potential despite of similar hematologic response rate, drug with effective organ reversing potential should be a standard treatment for amyloidosis.

The investigators assume that thalidomide could make organ reversal in cardiac amyloidosis due to its specific mechanism of action. To prove this concept, the investigators propose a clinical trial that evaluates organ reversing potential of thalidomide in cardiac amyloidosis.
Study Started
Oct 31
2016
Primary Completion
Sep 30
2019
Anticipated
Study Completion
Sep 30
2019
Anticipated
Last Update
Oct 26
2017

Drug Thalidomide

Drug Dexamethasone

Thalidomide Experimental

Patient with cardiac amyloidosis receive thalilomide with dexamethasone

Criteria 

Inclusion Criteria:

Age : more than 18 years old

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
ECOG(Eastern Cooperative Oncology Group) performance status ≤ 3
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
Expected survival > 3 months
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:

Amyloidosis without cardiac involvement
Patients who are planning to receive autologous stem cell transplantation
Patients who received autologous stem cell transplantation, remained in hematologic complete response
Pregnant, lactating or unwilling to use adequate contraception
Systemic infection unless specific anti-infective therapy is employed
Known allergies to thalidomide
Previous experimental agents or approved anti-tumor treatment within 1 months before the date of registration
No Results Posted