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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
  Purpose
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
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Study on QoL in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide

Resource links provided by NLM:


Further study details as provided by Hareth Nahi, Karolinska University Hospital:

Enrollment: 133
Study Start Date: November 2010
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430546


Locations
Sweden
Karolinska Institute
Stockholm, Sweden, S-141 86
Sponsors and Collaborators
Hareth Nahi
Investigators
Principal Investigator: Hareth Nahi, MD, PhD Karolinska University Hospital
  More Information

Responsible Party: Hareth Nahi, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01430546     History of Changes
Other Study ID Numbers: PI-RV-MM-10-06
First Submitted: September 7, 2011
First Posted: September 8, 2011
Last Update Posted: March 25, 2016
Last Verified: March 2016

Keywords provided by Hareth Nahi, Karolinska University Hospital:
Relapsed and Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents