Multiple Myeloma Clinical Trial
— REVLIMID-NISOfficial title:
Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma
| NCT number | NCT00911105 |
| Other study ID # | IOM-0810 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2009 |
| Est. completion date | November 2015 |
| Verified date | June 2018 |
| Source | iOMEDICO AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | November 2015 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Onkologische Schwerpunktpraxis | Bad Homburg | |
| Germany | Onkologische Praxis | Berlin | |
| Germany | Onkologische Schwerpunktpraxis | Berlin | |
| Germany | Onkologisches Versorgungszentrum Friedrichshain | Berlin | |
| Germany | Onkologische Gemeinschaftspraxis | Frankfurt am Main | |
| Germany | Praxis für Innere Medizin | Germering | |
| Germany | MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land | Groitzsch | |
| Germany | Internistische Gemeinschaftspraxis | Guestrow | |
| Germany | Praxis für Innere Medizin, Haematologie und Internistische Onkologie | Hamburg | |
| Germany | Tumorpraxis Heidenheim | Heidenheim | |
| Germany | Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert | Krefeld | |
| Germany | Onkologisches Zentrum Lebach | Lebach | |
| Germany | Onkologische Gemeinschaftspraxis | Lehrte | |
| Germany | Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer | Leipzig | |
| Germany | Praxis für Haematologie und Onkologie | Muehlheim | |
| Germany | Praxis fuer Innere Medizin | Neumarkt I. D. O. | |
| Germany | Praxis fuer Onkologie und Haematologie | Neuss | |
| Germany | Haematologisch-Onkologische Gemeinschaftspraxis | Nordhorn | |
| Germany | Onkologische Praxis Oldenburg | Oldenburg | |
| Germany | Onkologische Gemeinschaftspraxis | Wuerselen |
| Lead Sponsor | Collaborator |
|---|---|
| iOMEDICO AG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to progression (TTP) | maximum 3 years per Patient | ||
| Secondary | Overall Response Rate | maximum 3 years per Patient | ||
| Secondary | Time to Treatment Discontinuation (TTD) | maximum 3 years per Patient | ||
| Secondary | Overall Survival (OS) | maximum 3 years per Patient | ||
| Secondary | Safety Profile | maximum 3 years per Patient | ||
| Secondary | Dosage of Lenalidomide and Dexamethasone | maximum 3 years per Patient | ||
| Secondary | Kidney Function | maximum 3 years per Patient | ||
| Secondary | Neutropenia / Infection (Concomitant Medication) | maximum 3 years per Patient | ||
| Secondary | Thrombosis Prophylaxis | maximum 3 years per Patient |
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