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Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911105
First Posted: June 1, 2009
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
iOMEDICO AG
  Purpose
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.

Condition
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Time to progression (TTP) [ Time Frame: maximum 3 years per Patient ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: maximum 3 years per Patient ]
  • Time to Treatment Discontinuation (TTD) [ Time Frame: maximum 3 years per Patient ]
  • Overall Survival (OS) [ Time Frame: maximum 3 years per Patient ]
  • Safety Profile [ Time Frame: maximum 3 years per Patient ]
  • Dosage of Lenalidomide and Dexamethasone [ Time Frame: maximum 3 years per Patient ]
  • Kidney Function [ Time Frame: maximum 3 years per Patient ]
  • Neutropenia / Infection (Concomitant Medication) [ Time Frame: maximum 3 years per Patient ]
  • Thrombosis Prophylaxis [ Time Frame: maximum 3 years per Patient ]

Enrollment: 101
Study Start Date: May 2009
Study Completion Date: November 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with multiple myeloma
Patients with multiple myeloma receiving second line therapy or higher.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with mutiple myeloma receiving a combination therapy with Lenalidomide and Dexamethasone.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or nursing
  • All other exclusion criteria listed in SmPC (summary of product characteristics)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911105


Locations
Germany
Onkologische Schwerpunktpraxis
Bad Homburg, Germany, 61348
Onkologische Schwerpunktpraxis
Berlin, Germany, 10365
Onkologisches Versorgungszentrum Friedrichshain
Berlin, Germany, 10407
Onkologische Praxis
Berlin, Germany, 13439
Onkologische Gemeinschaftspraxis
Frankfurt am Main, Germany, 60389
Praxis für Innere Medizin
Germering, Germany, 82110
MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land
Groitzsch, Germany, 04539
Internistische Gemeinschaftspraxis
Guestrow, Germany, 18273
Praxis für Innere Medizin, Haematologie und Internistische Onkologie
Hamburg, Germany, 22587
Tumorpraxis Heidenheim
Heidenheim, Germany, 89518
Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert
Krefeld, Germany, 47805
Onkologisches Zentrum Lebach
Lebach, Germany, 66822
Onkologische Gemeinschaftspraxis
Lehrte, Germany, 31275
Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer
Leipzig, Germany, 04289
Praxis für Haematologie und Onkologie
Muehlheim, Germany, 45468
Praxis fuer Innere Medizin
Neumarkt i. d. O., Germany, 92318
Praxis fuer Onkologie und Haematologie
Neuss, Germany, 41462
Haematologisch-Onkologische Gemeinschaftspraxis
Nordhorn, Germany, 48527
Onkologische Praxis Oldenburg
Oldenburg, Germany, 26121
Onkologische Gemeinschaftspraxis
Wuerselen, Germany, 52146
Sponsors and Collaborators
iOMEDICO AG
  More Information

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00911105     History of Changes
Other Study ID Numbers: IOM-0810
First Submitted: May 28, 2009
First Posted: June 1, 2009
Last Update Posted: May 5, 2016
Last Verified: May 2016

Keywords provided by iOMEDICO AG:
Multiple Myeloma
Non-interventional study
Lenalidomide
Dexamethasone
Observational
Time to progression
Clinical routine
Germany
Plasmacytoma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Lenalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents