Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma
FIRST-NIS
A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
1 other identifier
observational
172
1 country
1
Brief Summary
The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2015
CompletedFirst Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedNovember 18, 2023
November 1, 2023
5.2 years
August 24, 2015
November 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) rate at 24 months
24 months
Secondary Outcomes (10)
To assess Median Overall Survival (OS)
84 month
To assess safety and tolerability via AE and SAE reporting
24 months
To assess Quality of Life (EORTC QLQ-C30 and MY20
24 months
To assess duration of hospitalisation periods
24 months
Overall Response Rate
24 months
- +5 more secondary outcomes
Eligibility Criteria
Transplant-ineligible patients with previously untreated, symptomatic multiple myeloma (as defined by IMWG criteria) and with an indication for medical treatment as assessed by the investigator.
You may qualify if:
- Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG)
- Indication for treatment as assessed by the treating physician
- Decision for first line combination therapy with lenalidomide and low-dose dexamethasone
- No previous systemic therapy for multiple myeloma
- Ineligibility for transplantation
- Aged 18 years or older
- Written informed consent signed
- The conditions of the risk management plan/pregnancy prevention program (refer to the SmPC Revlimid®) must be followed by female and male patients
- Other criteria according to the SmPC. Special warnings and precautions of the SmPC have to be considered by the treating physician
You may not qualify if:
- Pregnant or breast-feeding women
- Any objections or contraindications according to the SmPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iOMEDICO AGlead
Study Sites (1)
Hämatologisch-Onkologische Schwerpunktpraxis
Bochum, 44787, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holger Nückel, Professor
Hämatologisch-Onkologische Schwerpunktpraxis
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2015
First Posted
September 2, 2015
Study Start
June 23, 2015
Primary Completion
September 1, 2020
Study Completion
September 13, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share