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A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsed or Refractory Multiple Myeloma

Intervention: Lenalidomide (Drug); dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Axel Glasmacher, MD, Principal Investigator, Affiliation: University of Bonn

Summary

This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone. This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany. Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this open-label single-arm study. Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles. Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany. Upon discontinuation from study, minimal information was collected in order to identify when disease progressed.

Clinical Details

Official title: A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Kaplan Meier Estimate for Time to Disease Progression

Secondary outcome:

Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria

Participants With Treatment-emergent Adverse Experiences (TEAEs)

Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must understand and voluntarily sign an informed consent form.

- Must be ≥18 years of age at the time of signing the informed consent form.

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

- Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles

of anti-myeloma treatment or that has relapsed with progressive disease after treatment.

- Subjects may have been previously treated with thalidomide and/or radiation therapy.

In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.

- Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the

first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).

- Measurable levels of myeloma paraprotein in serum (>0. 5 g/dL) or urine (>0. 2 g

excreted in a 24-hour collection sample).

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

- Females of childbearing potential (FCBP) must agree to use two reliable forms of

contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. Exclusion Criteria:

- The presence of any of the following will exclude a subject from study enrollment:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that

would prevent the subject from signing the informed consent form.

- Pregnant or lactating females.

- Any condition, including the presence of laboratory abnormalities, which places the

subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

- Any of the following laboratory abnormalities:

- Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1. 0 x 10^9/L)

- Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone

marrow nucleated cells are plasma cells.

- Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom ≥50% of bone marrow

nucleated cells are plasma cells.

- Serum creatinine >2. 5 mg/dL (221 µmol/L)

- Serum SGOT/AST or SGPT/ALT >3. 0 x upper limit of normal (ULN)

- Serum total bilirubin >2. 0 mg/dL (34 µmol/L)

- Prior history of malignancies other than multiple myeloma (except for basal cell or

squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥1 year.

- Prior history of stroke and/or thromboembolic event

- Known hypersensitivity to thalidomide or dexamethasone.

- Prior history of uncontrollable side effects to dexamethasone therapy.

- The development of a desquamating rash while taking thalidomide.

- Neuropathy ≥ Grade 2.

Locations and Contacts

Medizinische Klinik und Poliklinik II der Charité Universitätsmedizin Berlin Campus Mitte, Berlin 10117, Germany

Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH, Bonn 53113, Germany

Poliklinik I, Hämatologie/ Onkologie, Universitätsklinikum Bonn, Bonn 53105, Germany

Medizinische Klinik Städtisches Klinikum Braunschweig gGmbH, Braunschweig D-38114, Germany

Interne Klinik Dr. Argirov, Schön-Kliniken, Burg 82335, Germany

Klinik für Innere Medizin III Klinikum Chemnitz gGmbH, Chemnitz 09113, Germany

Medizinische Klinik und Poliklinik, Uniklinikum Dresden, Dresden 01307, Germany

Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, Düsseldorf 40225, Germany

Direktor der Klinik f. Hämatologie, Universitätsklinikum Essen, Essen 45122, Germany

Universitätsklinikum EssenInnere Klinik und Poliklinik, Essen 45122, Germany

Klinik für Innere Medizin, Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder) 15236, Germany

Medizinische Klinik II (ZIM),Hämatologie / Onkologie Uniklinik Frankfurt, Frankfurt am Main 60590, Germany

Abt. Innere Medizin I , Hämatologie / Onkologie, Universitätsklinikum Freiburg, Freiburg 79106, Germany

Universitätsklinikum GöttingenHamatologie und Onkologie, Göttingen 37075, Germany

II. Medizinische Abteilung, Asklepios Klinikum Altona, Hamburg 22763, Germany

Interdisziplinäre Klinik und Poliklinik für Stammzellentransplantation Universitätsklinik Hamburg - Eppendorf, Hamburg 20246, Germany

Abt. Hämatologie, Hämatologie und Onkologie, Medizinische Hochschule Hannover, Hannover 30625, Germany

Medizinische Klinik und Poliklinik V Universitaetsklinikum Heidelberg, Heidelberg 69120, Germany

EPS - Early Phase Solutions GmbH, Jena 07743, Germany

Klinik für Innere Medizin II Hämatologie / Onkologie Universitätsklinikum Jena, Jena 07740, Germany

Hämatologie / Onkologie / Infektionskrankheiten, Palliativmedizin Städtisches Klinikum Karlsruhe, Karlsruhe 76135, Germany

2. Med. Klinik , Sektion f. Stammzell- + Immuntherapie Universitätsklinikum Schleswig-Holstein, Kiel 24105, Germany

Institut für Versorgungsforschung in der Onkologie Praxisklinik für Hämatologie und Onkologie, Koblenz 56068, Germany

Klinik f. Innere Medizin, Klinikum der Universität zu Köln, Köln 50924, Germany

Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hämatologie u. Onkologie, Köln 50677, Germany

Medizinische Klinik und Poliklinik II Abt. Hämatologie / Onkologie, Universitätsklinikum Leipzig AÖR, Leipzig 04103, Germany

III. Med. Klinik, Johannes Gutenberg Universität, Mainz 55101, Germany

Klinikum Mannheim der Universität Heidelberg, Mannheim 68305, Germany

Hämatologisch-Onkologisches Institut für medizinische Service Leistungen, Mönchengladbach 41239, Germany

Medizinische Klinik III Klinikum der Universität München-Großhadern, München 81377, Germany

Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis, Münster 48149, Germany

Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster, Münster 48129, Germany

Abt. Onkologie/ Hämatologie, Klinikum Oldenburg, Oldenburg 26133, Germany

Onkologie Praxis Oldenburg, Oldenburg 26121, Germany

Abteilung Hämatologie und Onkologie, Hämatologie und Onkologie, Medizinische Klinik, Klinikum Ernst v. Bergmann, Potsdam 14467, Germany

Klinikum der Universität Regensburg, Regensburg 93053, Germany

Abteilung Hämatologie und Onkologie, Medizinische Fakultät der Universität Rostock, Rostock 18057, Germany

Caritasklinik St. Theresia, Saarbrucken 66113, Germany

ms² Medizinische Statistik Saarbrücken, Saarbrucken D-66113, Germany

Med. Klinik III , St. Marienkrankenhaus Siegen, Siegen 57072, Germany

Zentrum für Innere Medizin II Robert- Bosch-Krankenhaus GmBH, Stuttgart D -70376, Germany

Krankenanstalt Mutterhaus der Borromäerinnen, Trier 54290, Germany

Abt. II Hämatologie, Onkologie und Immunologie Medizinische Klinik Abt.II, Tübingen 72076, Germany

Medizinische Universitätsklinik, Ulm 89081, Germany

Praxis Dres. Maintz & GroschekHämatologie / Onkologie, Wuerselen 52146, Germany

Med. Klinik 1, Helios Klinikum Wuppertal, Wuppertal 42283, Germany

Hämatologisch-onkologische Praxis, Würzburg D-97070, Germany

Med. Klinik u. Poliklinik IIKlinikum der Universität Würzburg, Würzburg 97080, Germany

Additional Information

Starting date: March 2007
Last updated: September 26, 2011

Page last updated: August 23, 2015

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