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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00911105
First received: May 28, 2009
Last updated: March 11, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
  • Time to Treatment Discontinuation (TTD) [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
  • Safety Profile [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: Yes ]
  • Dosage of Lenalidomide and Dexamethasone [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
  • Kidney Function [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
  • Neutropenia / Infection (Concomitant Medication) [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
  • Thrombosis Prophylaxis [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00911105     History of Changes
Other Study ID Numbers: IOM-0810
Study First Received: May 28, 2009
Last Updated: March 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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 acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 29, 2014