Clinical trial · Observational
Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma
Prospective Observational Study Evaluating the Safety of Lenalidomide/Dexamethasone Treatment in Patients With Relapsed or Refractory Multiple Myeloma
NCT02692339CI-TRIAL-00059420PrObe-LcompletedClinicalTrials.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)
Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Lenalidomide/Dexamethasone
- description
- Standard of Care doses for relapsed/refractory multiple myeloma
- interventionNames
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Number of Adverse events of special interest during Len/Dex therapy
- timeFrame
- Up to approximately 72 months
- description
- Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, i.e. any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Progression of the underlying disease of multiple myeloma is not considered an AE and should not be reported as an AE
Secondary outcomes (4)
- measure
- Incidence (number) of thromboembolism
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 18 years or higher. 2. Patients who have voluntarily given written informed consent to participate in the study and have their data retrieved for the purposes of the study 3. Patients diagnosed with 1st or 2nd relapsed or refractory multiple myeloma and indicated for 2nd or 3rd line Len/Dex treatment, according with the SmPC (patients who have received at least one prior therapy) - Exclusion Criteria: 1. Pregnant or lactating patients 2. Female patients of childbearing potential unable or unwilling to use effective contraceptive methods, as stated in the summary of product characteristics: * Implant. * Levonorgestrel-releasing intrauterine system. * Medroxyprogesterone acetate depot. * Tubal sterilisation. * Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses. Ovulation inhibitory progesterone-only pills (i.e. desogestrel). \- Male patients unable to follow or comply with the required contraceptive measures stated in the SmPC (use of condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception \[even if the man has had a vasectomy\], during treatment and for 1 week after dose interruptions and/or cessation of treatment) 3. Hypersensitivity to the active substance or any of the excipients 4. Patients participating in a clinical trial -
References
Publications (0)
Data not yet available
No reference posted for this study.