Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis
NCT ID: NCT02966522
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2016-10-31
2019-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thalidomide
Patient with cardiac amyloidosis receive thalilomide with dexamethasone
Thalidomide
Dexamethasone
Interventions
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Thalidomide
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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CW pharmaceutical company
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Youngil Koh
Clinical professor
Principal Investigators
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Youngil Koh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Youngil Koh, MD, PhD
Role: primary
Ryul Kim, MD
Role: backup
References
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Kastritis E, Dimopoulos MA. Recent advances in the management of AL Amyloidosis. Br J Haematol. 2016 Jan;172(2):170-86. doi: 10.1111/bjh.13805. Epub 2015 Oct 22.
Gatt ME, Palladini G. Light chain amyloidosis 2012: a new era. Br J Haematol. 2013 Mar;160(5):582-98. doi: 10.1111/bjh.12191. Epub 2013 Jan 7.
Dispenzieri A, Buadi F, Laumann K, LaPlant B, Hayman SR, Kumar SK, Dingli D, Zeldenrust SR, Mikhael JR, Hall R, Rajkumar SV, Reeder C, Fonseca R, Bergsagel PL, Stewart AK, Roy V, Witzig TE, Lust JA, Russell SJ, Gertz MA, Lacy MQ. Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis. Blood. 2012 Jun 7;119(23):5397-404. doi: 10.1182/blood-2012-02-413161. Epub 2012 Apr 4.
Dispenzieri A, Lacy MQ, Zeldenrust SR, Hayman SR, Kumar SK, Geyer SM, Lust JA, Allred JB, Witzig TE, Rajkumar SV, Greipp PR, Russell SJ, Kabat B, Gertz MA. The activity of lenalidomide with or without dexamethasone in patients with primary systemic amyloidosis. Blood. 2007 Jan 15;109(2):465-70. doi: 10.1182/blood-2006-07-032987. Epub 2006 Sep 28.
Kastritis E, Terpos E, Roussou M, Gavriatopoulou M, Pamboukas C, Boletis I, Marinaki S, Apostolou T, Nikitas N, Gkortzolidis G, Michalis E, Delimpasi S, Dimopoulos MA. A phase 1/2 study of lenalidomide with low-dose oral cyclophosphamide and low-dose dexamethasone (RdC) in AL amyloidosis. Blood. 2012 Jun 7;119(23):5384-90. doi: 10.1182/blood-2011-12-396903. Epub 2012 Apr 18.
Lee SP, Lee ES, Choi H, Im HJ, Koh Y, Lee MH, Kwon JH, Paeng JC, Kim HK, Cheon GJ, Kim YJ, Kim I, Yoon SS, Seo JW, Sohn DW. 11C-Pittsburgh B PET imaging in cardiac amyloidosis. JACC Cardiovasc Imaging. 2015 Jan;8(1):50-59. doi: 10.1016/j.jcmg.2014.09.018. Epub 2014 Nov 4.
Other Identifiers
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H-1512-129-730
Identifier Type: -
Identifier Source: org_study_id