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

NCT ID: NCT00478777

Last Updated: 2011-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-08-31

Brief 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.

Conditions

Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lenalidomide plus dexamethasone

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression.

dexamethasone

Intervention Type: DRUG

Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.

Interventions

Lenalidomide

Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression.

Intervention Type: DRUG

dexamethasone

Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.

Intervention Type: DRUG

Other Intervention Names

Revlimid®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Glasmacher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

Medizinische Klinik und Poliklinik II der Charité Universitätsmedizin Berlin Campus Mitte

Berlin, , Germany

Poliklinik I, Hämatologie/ Onkologie, Universitätsklinikum Bonn

Bonn, , Germany

Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH

Bonn, , Germany

Medizinische Klinik Städtisches Klinikum Braunschweig gGmbH

Braunschweig, , Germany

Interne Klinik Dr. Argirov, Schön-Kliniken

Burg, , Germany

Klinik für Innere Medizin III Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hämatologie u. Onkologie

Cologne, , Germany

Klinik f. Innere Medizin, Klinikum der Universität zu Köln

Cologne, , Germany

Medizinische Klinik und Poliklinik, Uniklinikum Dresden

Dresden, , Germany

Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

Düsseldorf, , Germany

Direktor der Klinik f. Hämatologie, Universitätsklinikum Essen

Essen, , Germany

Universitätsklinikum EssenInnere Klinik und Poliklinik

Essen, , Germany

Klinik für Innere Medizin, Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), , Germany

Medizinische Klinik II (ZIM),Hämatologie / Onkologie Uniklinik Frankfurt

Frankfurt am Main, , Germany

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

Freiburg im Breisgau, , Germany

Universitätsklinikum GöttingenHamatologie und Onkologie

Göttingen, , Germany

Interdisziplinäre Klinik und Poliklinik für Stammzellentransplantation Universitätsklinik Hamburg - Eppendorf

Hamburg, , Germany

II. Medizinische Abteilung, Asklepios Klinikum Altona

Hamburg, , Germany

Abt. Hämatologie, Hämatologie und Onkologie, Medizinische Hochschule Hannover

Hanover, , Germany

Medizinische Klinik und Poliklinik V Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Klinik für Innere Medizin II Hämatologie / Onkologie Universitätsklinikum Jena

Jena, , Germany

EPS - Early Phase Solutions GmbH

Jena, , Germany

Hämatologie / Onkologie / Infektionskrankheiten, Palliativmedizin Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

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

Kiel, , Germany

Institut für Versorgungsforschung in der Onkologie Praxisklinik für Hämatologie und Onkologie

Koblenz, , Germany

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

Leipzig, , Germany

III. Med. Klinik, Johannes Gutenberg Universität

Mainz, , Germany

Klinikum Mannheim der Universität Heidelberg

Mannheim, , Germany

Hämatologisch-Onkologisches Institut für medizinische Service Leistungen

Mönchengladbach, , Germany

Medizinische Klinik III Klinikum der Universität München-Großhadern

München, , Germany

Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster

Münster, , Germany

Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

Münster, , Germany

Onkologie Praxis Oldenburg

Oldenburg, , Germany

Abt. Onkologie/ Hämatologie, Klinikum Oldenburg

Oldenburg, , Germany

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

Potsdam, , Germany

Klinikum der Universität Regensburg

Regensburg, , Germany

Abteilung Hämatologie und Onkologie, Medizinische Fakultät der Universität Rostock

Rostock, , Germany

Caritasklinik St. Theresia

Saarbrücken, , Germany

ms² Medizinische Statistik Saarbrücken

Saarbrücken, , Germany

Med. Klinik III , St. Marienkrankenhaus Siegen

Siegen, , Germany

Zentrum für Innere Medizin II Robert- Bosch-Krankenhaus GmBH

Stuttgart, , Germany

Krankenanstalt Mutterhaus der Borromäerinnen

Trier, , Germany

Abt. II Hämatologie, Onkologie und Immunologie Medizinische Klinik Abt.II

Tübingen, , Germany

Medizinische Universitätsklinik

Ulm, , Germany

Med. Klinik 1, Helios Klinikum Wuppertal

Wuppertal, , Germany

Praxis Dres. Maintz & GroschekHämatologie / Onkologie

Würselen, , Germany

Med. Klinik u. Poliklinik IIKlinikum der Universität Würzburg

Würzburg, , Germany

Hämatologisch-onkologische Praxis

Würzburg, , Germany

Countries

Germany

References

Weisel, Katja Christina, et. al. Speed of Response with Lenalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma: First Results of the MM-019 Compassionate Use Protocol. 14th Congress of the European Hematology Association, June 2009. Haematologica 2009; 94(Suppl 2):160 abs.0397. http://www.eventure-online.com/eventure/publicAbstractView.do?id=101710&congressId=2432

Reference Type: RESULT

Other Identifiers

2006-004532-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-5013-MM-019

Identifier Type: -

Identifier Source: org_study_id