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

May 28, 2009
March 11, 2014
May 2009
April 2012   (final data collection date for primary outcome measure)
Time to progression (TTP) [ Time Frame: maximum 3 years per Patient ] [ Designated as safety issue: No ]
Time to progression (TTP) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00911105 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall Response Rate [ Designated as safety issue: No ]
  • Time to Treatment Discontinuation (TTD) [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Designated as safety issue: No ]
  • Safety Profile [ Designated as safety issue: Yes ]
  • Dosage of Lenalidomide and Dexamethasone [ Designated as safety issue: No ]
  • Kidney Function [ Time Frame: 3 years per patient ] [ Designated as safety issue: No ]
  • Neutropenia / Infection (Concomitant Medication) [ Designated as safety issue: No ]
  • Thrombosis Prophylaxis [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone
Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Multiple Myeloma
Not Provided
Patients with multiple myeloma
Patients with multiple myeloma receiving second line therapy or higher.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
May 2014
April 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00911105
IOM-0810
No
iOMEDICO AG
iOMEDICO AG
Not Provided
Not Provided
iOMEDICO AG
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP