Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q

NCT01081431 | Completed Phase 2 DMC

• 3 other identifiers: RV-MDS-PI-4092008-001866-10GMIHO-003/2008
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes; MDS; deletion 5q; del 5q; IPSS; low risk; intermediate-1 risk; GMIHO; ClinAssess; Germing; Düsseldorf; MDS-LE-MON-5; Lenalidomide; Revlimid

Outcome Measures

Primary Outcomes (1)

• To identify predictive factors for disease progression in patients with MDS and an isolated deletion del(5q), blast count <5%, undergoing treatment with lenalidomide

  maximum 4 years

Secondary Outcomes (2)

• Transfusion Independency on 56 consecutive days after enrollment

  maximum 4 years

• Cytologic Review

  maximum 4 years

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

10 mg d1-d21 of a 28-day cycle

Also known as: CC5013, CC-5013, Revlimid

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead
• ClinAssess GmbH: collaborator

Study Sites (12)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307, Germany

Location

Kath. Klinikum Duisburg

Duisburg, 47166, Germany

Location

Heinrich Heine Universität Düsseldorf

Düsseldorf, 40225, Germany

Location

Klinikum der J.W. Goethe Universität

Frankfurt, 60590, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

TU München - Klinikum rechts der Isar

München, 81675, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Related Links

• MDS Register

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ulrich Germing, Prof.

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 5, 2010
• Study Start: March 26, 2010
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: February 23, 2024

Record last verified: 2017-09

Locations

DE (12)