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Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430546
First Posted: September 8, 2011
Last Update Posted: March 25, 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):
Hareth Nahi, Karolinska University Hospital
September 7, 2011
September 8, 2011
March 25, 2016
November 2010
January 2016   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01430546 on ClinicalTrials.gov Archive Site
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Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line
Phase IV Study on QoL in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide
The purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
primary care clinic
Multiple Myeloma
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
Not Provided
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Be at least 18 years of age
  2. Have a confirmed diagnosis of MM
  3. Starting lenalidomide treatment for MM (due to relapsed or refractory disease) after one prior treatment.
  4. Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
  5. Must be willing and able to understand and comply with the study requirements.

Exclusion Criteria:

  1. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
  2. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01430546
PI-RV-MM-10-06
Yes
Not Provided
Not Provided
Hareth Nahi, Karolinska University Hospital
Hareth Nahi
Not Provided
Principal Investigator: Hareth Nahi, MD, PhD Karolinska University Hospital
Karolinska University Hospital
March 2016