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