Clinical trial · Observational
Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma
A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
NCT02537808CI-TRIAL-00071423FIRST-NIScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival (PFS) rate at 24 months
- timeFrame
- 24 months
Secondary outcomes (10)
- measure
- To assess Median Overall Survival (OS)
- timeFrame
- 84 month
- measure
- To assess safety and tolerability via AE and SAE reporting
- timeFrame
- 24 months
- description
- AE, SAE and ADR are documented in the eCRF and will be used for safety assessment.
- measure
- To assess Quality of Life (EORTC QLQ-C30 and MY20
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant or breast-feeding women * Any objections or contraindications according to the SmPC
References
Publications (1)
- DERIVEDNuckel H, Behlendorf T, Schulz H, Schulze M, Schardt C, Medinger T, Koenigsmann M, Dechow T, Indorf M, Burkle D, Engelbertz V, Rauh J, Schmidt B, Sauer A, Vannier C, Potthoff K. Lenalidomide Plus Dexamethasone as FIRST-Line Therapy in Transplant-Ineligible Patients With Multiple Myeloma: Final Results of the Prospective, Non-Interventional Study FIRST-NIS and Comparison With the FIRST Pivotal Phase III Clinical Trial. Cancer Med. 2026 Apr;15(4):e71758. doi: 10.1002/cam4.71758. PMID 41927857