NCT00911105

Brief Summary

Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

May 28, 2009

Last Update Submit

June 4, 2018

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaNon-interventional studyLenalidomideDexamethasoneObservationalTime to progressionClinical routineGermanyPlasmacytoma

Outcome Measures

Primary Outcomes (1)

  • Time to progression (TTP)

    maximum 3 years per Patient

Secondary Outcomes (8)

  • Overall Response Rate

    maximum 3 years per Patient

  • Time to Treatment Discontinuation (TTD)

    maximum 3 years per Patient

  • Overall Survival (OS)

    maximum 3 years per Patient

  • Safety Profile

    maximum 3 years per Patient

  • Dosage of Lenalidomide and Dexamethasone

    maximum 3 years per Patient

  • +3 more secondary outcomes

Study Arms (1)

Patients with multiple myeloma

Patients with multiple myeloma receiving second line therapy or higher.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mutiple myeloma receiving a combination therapy with Lenalidomide and Dexamethasone.

You may qualify if:

  • Patients with multiple myeloma with at least one previous therapy.
  • years or older
  • Signed, written informed consent

You may not qualify if:

  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Onkologische Schwerpunktpraxis

Bad Homburg, 61348, Germany

Location

Onkologische Schwerpunktpraxis

Berlin, 10365, Germany

Location

Onkologisches Versorgungszentrum Friedrichshain

Berlin, 10407, Germany

Location

Onkologische Praxis

Berlin, 13439, Germany

Location

Onkologische Gemeinschaftspraxis

Frankfurt am Main, 60389, Germany

Location

Praxis für Innere Medizin

Germering, 82110, Germany

Location

MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land

Groitzsch, 04539, Germany

Location

Internistische Gemeinschaftspraxis

Güstrow, 18273, Germany

Location

Praxis für Innere Medizin, Haematologie und Internistische Onkologie

Hamburg, 22587, Germany

Location

Tumorpraxis Heidenheim

Heidenheim, 89518, Germany

Location

Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert

Krefeld, 47805, Germany

Location

Onkologisches Zentrum Lebach

Lebach, 66822, Germany

Location

Onkologische Gemeinschaftspraxis

Lehrte, 31275, Germany

Location

Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer

Leipzig, 04289, Germany

Location

Praxis für Haematologie und Onkologie

Mühlheim, 45468, Germany

Location

Praxis fuer Innere Medizin

Neumarkt I. D. O., 92318, Germany

Location

Praxis fuer Onkologie und Haematologie

Neuss, 41462, Germany

Location

Haematologisch-Onkologische Gemeinschaftspraxis

Nordhorn, 48527, Germany

Location

Onkologische Praxis Oldenburg

Oldenburg, 26121, Germany

Location

Onkologische Gemeinschaftspraxis

Würselen, 52146, Germany

Location

MeSH Terms

Conditions

Multiple MyelomaPlasmacytoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2012

Study Completion

November 1, 2015

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

DE(20)