Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003746

Trial Description

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Title

A Multicenter, Single-arm, Open-label Phase II Study of the Safety of Lenalidomide Monotherapy and Markers for Disease Progression in Patients With IPSS Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Associated With an Isolated Deletion 5q Cytogenetic Abnormality (Del 5q)

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Trial Acronym

MDS-LE-MON-5

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine the safety of lenalidomide and markers for disease
progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.

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Brief Summary in Scientific Language

Lenalidomide has been successfully used in patients with MDS in several studies. A small
proportion of patients with MDS and del(5q) developed leukemia while treated with
Lenalidomide. Up to now it is unknown what patients are at risk to progress while being
treated with Lenalidomid. Therefore it is planned to examine not only the traditional
clinical parameters like disease status and proportion of blasts, but also cytogenetic
findings, gene expression, antiangiogenic effect, marrow fibrosis, mesenchymal stem cell as
well as mitochondrial DNA mutation at baseline and in the course of the study performed by
central laboratories. Moreover, long-term data are required, e.g., with regard to the
development of AML. Therefore, it is planned to collect data from all patients with MDS and
del 5q (isolated, blast count <5%) in whom treatment with lenalidomide is the best
therapeutic option according to the investigator's assessment in a structured fashion.

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Organizational Data

  •   DRKS00003746
  •   2012/05/02
  •   2010/03/02
  •   yes
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Secondary IDs

  •   2008-001866-10 
  •   NCT01081431  (ClinicalTrials.gov)
  •   RV-MDS-PI-409  (Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH)
  •   GMIHO-003/2008 
  •   2008-001866-10 
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Health Condition or Problem studied

  •   Myelodysplastic Syndromes
  •   D46 -  Myelodysplastic syndromes
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Interventions/Observational Groups

  •   Drug: Lenalidomide
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- To identify predictive factors for disease progression in patients with MDS and an isolated deletion del(5q), blast count <5%, undergoing treatment with lenalidomide; time frame: maximum 4 years

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Secondary Outcome

- Transfusion Independency on 56 consecutive days after enrollment; time frame: maximum 4 years
- Cytologic Review; time frame: maximum 4 years; Investigation of bone marrow to identify blasts, ringed sideroblasts and dysplastic changes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/03/31
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Must understand and voluntarily sign an informed consent form

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

- Must be able to adhere to the study visit schedule and other protocol requirements

- Cytologically/histologically confirmed diagnosis of MDS with del 5q (isolated, blast
count <5%), IPSS low or intermediate-1.

- Transfusion dependency with at least 1 concentrates of erythrocytes within 8 weeks
prior to first administration of study drug.

- Start of treatment with lenalidomide is the best therapeutic option for the patient
according to the investigator's assessment There are - apart from individual cases
with erythropoetin level lower than 500 U/l and allogeneic transplantation for
younger patients - no authorized alternative treatment options. Chemotherapy with low
dose cytosine arabinoside may result in hematologic improvement. However, concerning
the risk-benefit-assessment this chemotherapy is more unfavorable than lenalidomide
due to cytopenia and mutagenic effects.

- Female subjects of childbearing potential must:

- Understand that the study medication has a teratogenic risk

- Agree to use, and be able to comply with, effective contraception without
interruption, 4 weeks before starting study drug, throughout study drug therapy
(including dose interruptions) and for 4 weeks after the end of study drug
therapy, even if she has amenorrhoea. This applies unless the subject commits to
absolute and continued abstinence confirmed on a monthly basis. The following
are effective methods of contraception*: (Implant,Levonorgestrel-releasing
intrauterine system (IUS)**,Medroxyprogesterone acetate depot, Tubal
sterilisation, Sexual intercourse with a vasectomised male partner only;
vasectomy must be confirmed by two negative semen analyses, Ovulation inhibitory
progesterone-only pills (i.e., desogestrel))

- Agree to have a medically supervised pregnancy test with a minimum sensitivity
of 25 mIU/ml not more than 3 days before the start of study medication once the
subject has been on effective contraception for at least 4 weeks. This
requirement also applies to women of childbearing potential who practice
complete and continued abstinence.

- Agree to have a medically supervised pregnancy test every 4 weeks including 4
weeks after the end of study treatment, except in the case of confirmed tubal
sterilization. These tests should be performed not more than 3 days before the
start of next treatment. This requirement also applies to women of childbearing
potential who practice complete and continued abstinence

(*) Combined oral contraceptive pills are not recommended. If a subject was using combined
oral contraception, she must switch to one of the methods above. The increased risk of VTE
continues for 4 to 6 weeks after stopping combined oral contraception.

(**) Prophylactic antibiotics should be considered at the time of insertion particularly
in patients with neutropenia due to risk of infection

- Male subjects must

- Agree to use condoms throughout study drug therapy, during any dose interruption
and for one week after cessation of study therapy if their partner is of
childbearing potential and has no contraception.

- Agree not to donate semen during study drug therapy and for one week after end
of study drug therapy.

- All subjects must

- Agree to abstain from donating blood while taking study drug therapy and for one
week following discontinuation of study drug therapy.

- Agree not to share study medication with another person and to return all unused
study drug to the investigator

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Exclusion Criteria

- Pregnant or lactating females

- IPSS intermediate-2 or high-risk

- Proliferative (WBC ≥ 12 x 109/L) CMML

- Any of the following laboratory abnormalities:

- Absolute neutrophil count (ANC) < 1 x 109/L

- Platelet count < 50 x 109/L

- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase
(SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase
(SGPT) > 3.0 x upper limit of normal (ULN)

- Serum total bilirubin > 1.5 mg/dL Degree of severity of anemia is no exclusion
criteria due to intensive interindividual variations of the haemoglobin value at
time of transfusion.

- Prior ≥ grade-2 NCI CTCAE allergic reaction to thalidomide

- Prior desquamating (blistering) rash while taking thalidomide

- Neuropathy ≥ grade 2

- Clinically significant anemia owing to iron, B12, or folate deficiencies, or
autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must
have a marrow aspirate that is evaluable for storage iron)

- Prior history of malignancy other than MDS (except basal cell or squamous cell
carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been
free of disease for ≥ 3 years

- Concomitant use of androgens (exception: treatment of hypogonadism)

- Concomitant use of specific treatments for MDS

- Known HIV-1 positivity

- Participation in another clinical study in the 4 weeks prior to enrollment or during
this study

- Prior treatment with lenalidomide

- Any serious medical condition or psychiatric illness that will prevent the subject
from signing the informed consent form or will place the subject at unacceptable risk
if he/she participates in the study.

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Addresses

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    • Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
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    •   [---]*
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    • ClinAssess GmbH
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Heinrich-Heine University, Duesseldorf
    • Ulrich Germing, Prof. 
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    • Heinrich-Heine University, Duesseldorf
    • Ulrich Germing, Prof. 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   94
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.