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

March 24, 2016 updated by: Hareth Nahi

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-141 86
        • Karolinska Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hareth Nahi

Investigators

  • Principal Investigator: Hareth Nahi, MD, PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-RV-MM-10-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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