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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01510613
Date of registration: 11/01/2012
Prospective Registration: Yes
Primary sponsor: IRCCS Policlinico S. Matteo
Public title: Pomalidomide and Dexamethasone (PDex) in AL Amyloidosis
Scientific title: An Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis.
Date of first enrolment: February 2012
Target sample size: 28
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01510613
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Italy
Contacts
Name:     Giampaolo Merlini, Prof.
Address: 
Telephone:
Email:
Affiliation:  Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S.Matteo
Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years.

- Diagnosis of systemic AL amyloidosis.

- Symptomatic organ (heart, kidney, liver, peripheral nervous system, or soft tissue)
involvement.

- Patients achieving less than complete response after initial treatment with an
alkylating agent (melphalan or cyclophosphamide) 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/uL.

- Platelet count = 100000/uL.

- 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.

- Female: FCBP must have two negative pregnancy tests (sensitivity of at least 50
mIU/mL) prior to starting study drug. The first pregnancy test must be performed
within 10-14 days prior to the start of study drug and the second pregnancy test must
be performed within 24 hours prior to the start of study drug. The subject may not
receive study drug until the Investigator has verified that the results of these
pregnancy tests are negative. Will be warned that sharing study drug is prohibited and
will be counseled about pregnancy precautions and potential risks of fetal exposure.
Must agree to abstain from donating blood during study participation and for at least
28 days after discontinuation from the study.

- Male: Must agree to use a latex condom during sexual contact with females of
childbearing potential while participating in the study and for at least 28 days
following discontinuation from the study even if he has undergone a successful
vasectomy. Will be warned that sharing study drug is prohibited and will be counseled
about pregnancy precautions and potential risks of fetal exposure. Must agree to
abstain from donating blood, semen, or sperm during study participation and for at
least 28 days after discontinuation from the study.

During study participation and for 28 days following discontinuation from the study:

- All subjects: No more than a 28-day supply of study drug will be dispensed at a time.

- Female: FCBP with regular cycles must agree to have pregnancy tests weekly for the
first 28 days of study participation and then every 28 days while on study, at study
discontinuation, and at day 28 following discontinuation from the study. If menstrual
cycles are irregular, the pregnancy testing must occur weekly for the first 28 days
and then every 14 days while on study, at study discontinuation, and at days 14 and 28
following discontinuation from the study. In addition to the required pregnancy
testing, the Investigator must confirm with FCBP that she is continuing to use two
reliable methods of birth control at each visit. Counseling about pregnancy
precautions and the potential risks of fetal exposure must be conducted at a minimum
of every 28 days. During counseling, subjects must be reminded to not share study drug
and to not donate blood. Pregnancy testing and counseling must be performed if a
subject misses her period or if her pregnancy test or her menstrual bleeding is
abnormal. Study drug treatment must be discontinued during this evaluation. Females
must agree to abstain from breastfeeding during study participation and for at least
28 days after discontinuation from the study.

- Male: Counseling about the requirement for latex condom use during sexual contact with
females of childbearing potential and the potential risks of fetal exposure must be
conducted at a minimum of every 28 days. During counseling, subjects must be reminded
to not share study drug and to not donate blood, sperm, or semen.

Exclusion Criteria:

- Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura as the only
evidence of disease.

- 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: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Primary Amyloidosis of Light Chain Type
Intervention(s)
Drug: Pomalidomide and Dexamethasone
Primary Outcome(s)
Efficacy of PDex [Time Frame: evaluation made at the end of each 28 days cycle]
Secondary Outcome(s)
Safety of PDex [Time Frame: evaluation made at the end of each 28 days cycle]
Secondary ID(s)
2011-001787-22
AC-007-IT
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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