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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: 16 December 2017
Main ID:  NCT01194791
Date of registration: 26/07/2010
Prospective Registration: Yes
Primary sponsor: PETHEMA Foundation
Public title: Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed LENDEXAL
Scientific title: A Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell Transplantation
Date of first enrolment: October 2010
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01194791
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Spain
Contacts
Name:     Bladé Joan, Dr
Address: 
Telephone:
Email:
Affiliation:  Hospital Clinic of Barcelona
Key inclusion & exclusion criteria

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form.

- Age > 18 years at the time of signing the informed consent form.

- Able to adhere to the study visit schedule and other protocol requirements according
with investigator criteria.

- Diagnosis of symptomatic primary systemic amyloidosis based on tissue Congo red
positive staining as well as positive immunohistochemical staining for light chains or
presence of a monoclonal protein in serum and/or urine or clonal bone marrow plasma
cells

- Previously untreated disease

- Patients should not candidates for up-front high-dose therapy/stem cell
transplantation

- Serologically measurable disease defined as follows:

Evidence of a monoclonal light chain in serum and urine by immunofixation Raise of the
level of circulating free light chains above the ordinary limits and an abnormal
relationship kappa/lambda.

- Performance status ECOG = 2 (see Annex 3).

- Laboratory tests results within these ranges:

Absolute neutrophil count = 1 x 10 9/ L. Platelet count = 100 x 10 9/ L Serum creatinine
less than 3.0 mg/dL Serum bilirubin less than 3.0 mg/dL

- Females of childbearing potential (FCBP) must agree to: Know the teratogenic risks of the
study drug

Commit to use contraceptives during the 4 weeks before the start of this study drug
treatment, during the treatment and also 4 weeks after it, even amenorrheic cases. All of
it applies always except women committed to maintain sexual abstinence confirming it
monthly. Some of effective contraceptives are:

Birth control implant Levonorgestrel-releasing intrauterine device. Depot
medroxyprogesterone acetate Tubal ligation Sexual intercourse only with a vasectomized
partner. The effectiveness of vasectomy must be confirmed by two semen analysis; the result
must be negative Inhibiting ovulation pill progesterone only (for example: desogestrel) if
it is determined that the patient doesn't use an effective contraceptive method will be
referred to a skilled health professional to receive advice on contraception, so that they
can begin to birth control measures.

It's discouraged combine oral contraceptives in myeloma multiple women cases treated with
Lenalidomide combined with Dexamethasone due to high venous thromboembolism risk. In case
these kind of patient were having combined oral contraceptives, she must change to another
one of list above. Risks of venous thromboembolism will remain during the 3 or 4 weeks
after discontinue combine oral contraceptives treatment. Concomitant treatment with
dexamethasone reduces the effectiveness of contraceptive steroids.

Implants and levonorgestrel-releasing intrauterine systems are related to higher risks of
infections at the moment of the implant or when there is metrorrhagia. It should be
considered prophylactic treatment with antibiotics for neutropenic patients.

Normally it's discouraged copper intrauterine devices because of the infection risk and
menstrual blood loss at the moment of the implant for patients with neutropenia or
thrombocytopenia.

Women patients must follow all warnings for an effective contraception, even if she is
amenorrheic.

Women patients must be aware about effects of pregnancy and go to a health care centre
urgently in case of pregnancy risk.

She must take a pregnancy test with a minimum sensitivity of 25 mUl/ml, under medical
supervision, when the study visits or three days before the visit, when she were 4 weeks at
least using effective contraceptive methods. This requirement applies for women who
practice a complete and continuous sexual abstinence. Test should confirm that the patient
is not pregnant at the time of starting treatment.

She must take a pregnancy test, under medical supervision, each 4 weeks, even a pregnancy
test 4 weeks after the end of the study treatment, except in case of a confirmed tubal
ligation. Pregnancy test should be performed the day of the study's visit or during the
three days before it. This requirement also applies for childbearing women who practice a
complete and continuous sexual abstinence.

- Male patients must: Undertake to use latex condoms during treatment with study medication
including all periods of interruption of doses, even one week after finishing treatment if
his partner is a woman of childbearing who doesn't use contraceptive methods.

Commit not to donate semen during treatment with study medication and even one week after
finishing treatment.

- All patients should: Refrain from donating blood during treatment with study medication
and even one week after finishing treatment.

Refrain from sharing the study medication with other people and return unused study
medication to the investigator or the pharmacist.

Exclusion Criteria:

- Localized cutaneous AL, only carpal tunnel syndrome, merely vascular amyloid in the
bone marrow biopsy, AL in a plasmacytoma or AL associated to multiple myeloma (>30%
plasma cells in bone marrow, lytic bone lesions, hypercalcemia, plasmacytomas).

- Other causes of amyloidosis (secondary, familial, senile).

- Candidates for high dose chemotherapy/ stem cell transplant.

- Previously treated AL.

- Any condition including laboratory abnormalities, which placed the subjects at
unacceptable risk if he/she were to participating the study or confounds the ability
to interpret data from the study.

- Use of any other experimental drug or therapy within 28 days prior to baseline.

- Any prior use of lenalidomide

- Any cancer in the previous 5 years, except no melanoma skin cancer, cervix or prostate
cancer treated in the initial state with prostate-specific antigen within normal
limits.

- Known positive for HIV.

- Cardiac ejection fraction below 50%

- Pregnant or breast-feeding (can not breast-feed while taking lenalidomide)

- Patients who are not able to use antithrombotic prophylaxis or reject.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Primary Systemic Amyloidosis
Intervention(s)
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Lenalidomide
Primary Outcome(s)
Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and Dexamethasone [Time Frame: 6 months]
Secondary Outcome(s)
Duration of response [Time Frame: 10 years]
Organ response rate [Time Frame: 6 months]
Overall survival [Time Frame: 10 yeras]
Predictors of response (cardiac biomarkers, serum free light chains) [Time Frame: 5 years]
Safety and tolerability [Time Frame: 5 years]
Time to progression [Time Frame: 5 years]
Secondary ID(s)
2009-017707-28
LENDEXAL
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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