World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 2 October 2012
Main ID:  EUCTR2011-001787-22-IT
Date of registration: 12/01/2012
Prospective Registration: Yes
Primary sponsor: OSPEDALE POLICLINICO S. MATTEO
Public title: Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.
Scientific title: An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex
Date of first enrolment: 02/05/2012
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001787-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Italy
Contacts
Name: Centro Amiloidosi   
Address:  Piazzale Golgi 19 27100 Pavia Italy
Telephone: 0382 502994
Email: centro.amiloidosi@smatteo.pv.it
Affiliation:  Fondazione IRCCS Policlinico San Matteo
Name: Centro Amiloidosi   
Address:  Piazzale Golgi 19 27100 Pavia Italy
Telephone: 0382 502994
Email: centro.amiloidosi@smatteo.pv.it
Affiliation:  Fondazione IRCCS Policlinico San Matteo
Key inclusion & exclusion criteria
Inclusion criteria:
• At least 18 years. • Diagnosis of systemic AL amyloidosis. Symptomatic organ involvement. • Patients achieving less than complete response after initial treatment with an alkylating agent and bortezomib. Patients with AL amyloidosis who received 1 previous treatment, but who could not be treated with alkylators and/or bortezomib due to contraindications, will be eligible. • Measurable disease: difference between amyloidogenic (involved) and uninvolved free light chains (dFLC) >50 mg/L. • Hb =10 g/dL • ANC =1500/mcL. • Platelet count =100000/mcL. • eGFR =30 mL/min per 1.73 m2. • Performance status (ECOG) <3. • Total bilirubin <2.5 mg/dL. • Alkaline phosphatase <5 × url. • ALT <3 × url. Subjects must be informed about pregnancy program prevention
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 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion criteria:
• Amyloid-specific syndrome • New York Heart association (NYHA) class IV. • Known positivity for HIV or active hepatitis infection. • Pregnant or nursing women (men must agree to use an acceptable method for contraception for the duration of the study). • Uncontrolled infections. • Other active malignancies. • Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism. • Known hypersensitivity to thalidomide or lenalidomide including development of erythema. • Previous or ongoing psychiatric illness (with the exclusion of reactive depression).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Previously treated AL amyloidosis
MedDRA version: 14.1 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Intervention(s)

Product Name: pomalidomide
Product Code: CC-4047
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pomalidomide
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 2-

Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE
CAS Number: 466-11-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)
Main Objective: To evaluate the efficacy of pomalidomide + dexamethasone (PDex) in patients who did not achieve a complete response after initial treatment with both an alkylating agent and bortezomib.
Primary end point(s): To assess the rate of hematologic response at 3 months
Secondary Objective: To assess the safety of PDex combination. To assess the survival of AL Amyloidosis patients treated with PDex.
Timepoint(s) of evaluation of this end point: 3 months
Secondary Outcome(s)
Secondary end point(s): Rate of adverse events. Rate of complete response at 3, 6, 9, and 12 months. Hematologic response rate at 6, 9, and 12 months. Organ response rate at 3, 6, 9, and 12 months. Progression-free survival. Overall survival.
Timepoint(s) of evaluation of this end point: See secondary endpoints
Secondary ID(s)
AC-007-IT
Source(s) of Monetary Support
Celgene International Sarl
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history