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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hareth Nahi, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01430546
First received: September 7, 2011
Last updated: September 24, 2014
Last verified: September 2014
  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 Karolinska University Hospital:

Estimated Enrollment: 120
Study Start Date: November 2010
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 7, 2011
Last Updated: September 24, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014