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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.
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital Identifier:
First received: September 7, 2011
Last updated: March 24, 2016
Last verified: March 2016
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.

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)

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

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
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Please refer to this study by its identifier: NCT01430546

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

Responsible Party: Hareth Nahi, MD, PhD, Karolinska University Hospital Identifier: NCT01430546     History of Changes
Other Study ID Numbers: PI-RV-MM-10-06
Study First Received: September 7, 2011
Last Updated: March 24, 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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on September 21, 2017