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Relapsed or Refractory Multiple MyelomaPhase 3NCT00478777

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

A Phase 3 study testing Lenalidomide and dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Celgene Corporation at 48 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Lenalidomide and dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
48 sitesGermany
Study dates
Mar 2007to Aug 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Germany48 sites

  • Medizinische Klinik und Poliklinik II der Charité Universitätsmedizin Berlin Campus Mitte

    Berlin, 10117

  • Poliklinik I, Hämatologie/ Onkologie, Universitätsklinikum Bonn

    Bonn, 53105

  • Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH

    Bonn, 53113

  • Medizinische Klinik Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, D-38114

  • Interne Klinik Dr. Argirov, Schön-Kliniken

    Burg, 82335

  • Klinik für Innere Medizin III Klinikum Chemnitz gGmbH

    Chemnitz, 09113

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

    Cologne, 50677

  • Klinik f. Innere Medizin, Klinikum der Universität zu Köln

    Cologne, 50924

  • Medizinische Klinik und Poliklinik, Uniklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

    Düsseldorf, 40225

  • Direktor der Klinik f. Hämatologie, Universitätsklinikum Essen

    Essen, 45122

  • Universitätsklinikum EssenInnere Klinik und Poliklinik

    Essen, 45122

  • Klinik für Innere Medizin, Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

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

    Frankfurt am Main, 60590

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

    Freiburg im Breisgau, 79106

  • Universitätsklinikum GöttingenHamatologie und Onkologie

    Göttingen, 37075

  • Interdisziplinäre Klinik und Poliklinik für Stammzellentransplantation Universitätsklinik Hamburg - Eppendorf

    Hamburg, 20246

  • II. Medizinische Abteilung, Asklepios Klinikum Altona

    Hamburg, 22763

  • Abt. Hämatologie, Hämatologie und Onkologie, Medizinische Hochschule Hannover

    Hanover, 30625

  • Medizinische Klinik und Poliklinik V Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Klinik für Innere Medizin II Hämatologie / Onkologie Universitätsklinikum Jena

    Jena, 07740

  • EPS - Early Phase Solutions GmbH

    Jena, 07743

  • Hämatologie / Onkologie / Infektionskrankheiten, Palliativmedizin Städtisches Klinikum Karlsruhe

    Karlsruhe, 76135

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

    Kiel, 24105

  • Institut für Versorgungsforschung in der Onkologie Praxisklinik für Hämatologie und Onkologie

    Koblenz, 56068

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

    Leipzig, 04103

  • III. Med. Klinik, Johannes Gutenberg Universität

    Mainz, 55101

  • Klinikum Mannheim der Universität Heidelberg

    Mannheim, 68305

  • Hämatologisch-Onkologisches Institut für medizinische Service Leistungen

    Mönchengladbach, 41239

  • Medizinische Klinik III Klinikum der Universität München-Großhadern

    München, 81377

  • Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster

    Münster, 48129

  • Fachärzte für Innere Medizin Hämatologie und Onkologie Gemeinschaftspraxis

    Münster, 48149

  • Onkologie Praxis Oldenburg

    Oldenburg, 26121

  • Abt. Onkologie/ Hämatologie, Klinikum Oldenburg

    Oldenburg, 26133

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

    Potsdam, 14467

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Abteilung Hämatologie und Onkologie, Medizinische Fakultät der Universität Rostock

    Rostock, 18057

  • Caritasklinik St. Theresia

    Saarbrücken, 66113

  • ms² Medizinische Statistik Saarbrücken

    Saarbrücken, D-66113

  • Med. Klinik III , St. Marienkrankenhaus Siegen

    Siegen, 57072

  • Zentrum für Innere Medizin II Robert- Bosch-Krankenhaus GmBH

    Stuttgart, D -70376

  • Krankenanstalt Mutterhaus der Borromäerinnen

    Trier, 54290

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

    Tübingen, 72076

  • Medizinische Universitätsklinik

    Ulm, 89081

  • Med. Klinik 1, Helios Klinikum Wuppertal

    Wuppertal, 42283

  • Praxis Dres. Maintz & GroschekHämatologie / Onkologie

    Würselen, 52146

  • Med. Klinik u. Poliklinik IIKlinikum der Universität Würzburg

    Würzburg, 97080

  • Hämatologisch-onkologische Praxis

    Würzburg, D-97070

Other trials in Germany

About this study

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.

Read more

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.

Keywords
CC-5013, Revlimid, Lenalidomide, Celgene, Multiple Myeloma
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid®

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

  • dexamethasoneDrug

    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.

Study groups in NCT00478777
Study groupRoleWhat they receive
lenalidomide plus dexamethasoneExperimentalLenalidomide 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.
Receives: Drug: Lenalidomide; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kaplan Meier Estimate for Time to Disease Progression

    Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease.

    Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

    Measured: up to 827 days

Secondary outcomes (3)

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

    Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD).

    CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.

    Measured: Up to 827 days

  2. Participants With Treatment-emergent Adverse Experiences (TEAEs)

    Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.

    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

    Measured: up to 8 months

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

    Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.

    Measured: up to 827 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionNov 2007
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00478777
Sponsor's protocol ID
CC-5013-MM-019
Other IDs
2006-004532-73
Status last verified
Sep 2011
First submitted
23 May 2007
Last updated
3 Nov 2011
Data monitoring committee
Yes

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide and dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Celgene Corporation at 48 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan Meier Estimate for Time to Disease Progression (time frame: up to 827 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00478777, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2011.

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