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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

Sponsor
Hareth Nahi (Other)
Overall Status
Completed
CT.gov ID
NCT01430546
Collaborator
(none)
133
Enrollment
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    133 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Phase IV Study on QoL in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2016

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Karolinska Institute Stockholm Sweden S-141 86

      Sponsors and Collaborators

      • Hareth Nahi

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Hareth Nahi, MD, PhD, Karolinska University Hospital
      ClinicalTrials.gov Identifier:
      NCT01430546
      Other Study ID Numbers:
      • PI-RV-MM-10-06
      First Posted:
      Sep 8, 2011
      Last Update Posted:
      Mar 25, 2016
      Last Verified:
      Mar 1, 2016
      Keywords provided by Hareth Nahi, MD, PhD, Karolinska University Hospital
      Relapsed and Refractory Multiple Myeloma
      Additional relevant MeSH terms:
      Multiple Myeloma
      Neoplasms, Plasma Cell

      Study Results

      No Results Posted as of Mar 25, 2016