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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Relapsed and/or Refractory Multiple Myeloma
- Sponsor
- Multinational Center for Quality of Life Research, Russia
- Enrollment
- 40
- Primary Endpoint
- Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
Time Frame: 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
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.
Changes in symptom severity while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
Time Frame: 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
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
Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone
Time Frame: Assessment will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start
Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone will be assessed at each time-point during treatment with ixazomib in combination with lenalidomide and dexamethasone
Secondary Outcomes
- Overall response rates and duration of response to treatment with ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)
- Overall survival (OS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)
- Frequency of adverse events (AEs)/serious AEs in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)
- Progression free survival (PFS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone(18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone)