Clinical trial · Observational
Quality of Life, Symptoms and Treatment Satisfaction in Adult Patients With Relapsed and/or Refractory Multiple Myeloma, Receiving Ixazomib (Ninlaro®) in Combination With Lenalidomide and Dexamethasone in a Real World Setting: Pilot Study
NCT03903406CI-TRIAL-00037935unknownClinicalTrials.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 purpose of this pilot study is to examine changes in patient-reported outcomes in patients with RRMM receiving triple therapy with ixazomib in combination with LenDex in a real world setting as well as to analyze clinical outcomes and safety of this treatment modality.
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 |
|---|---|---|---|
| Relapsed and/or Refractory Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixazomib in combination with lenalidomide and dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
- timeFrame
- Assessment of QoL changes will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start as compared to baseline
- description
- The change in QoL will be assessed as the difference in QoL means by scales of RAND SF-36 between any time-points during 18 mos of treatment and additionally as the difference in QoL means at any time-point as compared to baseline.
- measure
- Changes in symptom severity while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
- timeFrame
- Assessment of changes in symptom severity will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start
- description
- The change in symptom severity will be assessed as the difference in the severity of each ESAS-R scale, the symptom distress score and the severity of NRS for assessing tingling hands/feet between any time-points during 18 mos of treatment and additionally at each time-point as compared with their baseline value. The proportion of patients with ≥1 point improvement on ESAS-R scale and on NRS for assessing tingling hands/feet at each time-point will be analyzed as well
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with confirmed diagnosis of RRMM * At least 18 years of age at the time of treatment start * Patients who have received at least one prior therapy and who are suitable for treatment with ixazomib in combination with LenDex * Patients who gave informed consent * Patients who are capable to fill out questionnaires * Patients with expected life duration of at least 6 months Exclusion Criteria: * Patients currently enrolled in any other clinical trials * Patients with contraindications to ixazomib in accordance with instruction for use.
References
Publications (0)
Data not yet available
No reference posted for this study.