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NCT01430546 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
Phase IV Study on QoL in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01430546
Other study ID # PI-RV-MM-10-06
Secondary ID
Status Completed
Phase N/A
First received September 7, 2011
Last updated March 24, 2016
Start date November 2010

Study information
Verified date March 2016
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Karolinska Institute Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Hareth Nahi

Country where clinical trial is conducted

Sweden, 

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