Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line

NCT ID: NCT01430546

Last Updated: 2016-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hareth Nahi

OTHER

Sponsor Role lead

Responsible Party

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Hareth Nahi

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hareth Nahi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska Institute

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 29673108 (View on PubMed)

Other Identifiers

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PI-RV-MM-10-06

Identifier Type: -

Identifier Source: org_study_id

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