Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone
This study is ongoing, but not recruiting participants.
Sponsor:
iOMEDICO AG
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00911105
First received: May 28, 2009
Last updated: October 8, 2012
Last verified: October 2012
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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:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Lenalidomide
U.S. FDA Resources
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 |
| Estimated Primary Completion Date: | May 2013 (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
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: | October 8, 2012 |
| 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 May 16, 2013