NCT01430546

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

5.2 years

First QC Date

September 7, 2011

Last Update Submit

March 24, 2016

Conditions

Multiple Myeloma

Keywords

Relapsed and Refractory Multiple Myeloma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Be at least 18 years of age
  • Have a confirmed diagnosis of MM
  • Starting lenalidomide treatment for MM (due to relapsed or refractory disease) after one prior treatment.
  • Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
  • Must be willing and able to understand and comply with the study requirements.

You may not qualify if:

  • Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institute

Stockholm, S-141 86, Sweden

Location

Related Publications (1)

  • Lund J, Gruber A, Lauri B, Duru AD, Blimark C, Swedin A, Hansson M, Forsberg K, Ahlberg L, Carlsson C, Waage A, Gimsing P, Vangsted AJ, Frolund U, Holmberg E, Gahrton G, Alici E, Hardling M, Mellqvist UH, Nahi H. Lenalidomide versus lenalidomide + dexamethasone prolonged treatment after second-line lenalidomide + dexamethasone induction in multiple myeloma. Cancer Med. 2018 Jun;7(6):2256-2268. doi: 10.1002/cam4.1422. Epub 2018 Apr 19.

    PMID: 29673108DERIVED

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hareth Nahi, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 8, 2011

Study Start

November 1, 2010

Primary Completion

January 1, 2016

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

SE(1)