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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Relapsed and/or Refractory Multiple Myeloma

Intervention / Treatment
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* Drug: ixazomib in combination with lenalidomide and dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixazomib in combination with lenalidomide and dexamethasone|Patients with RRMM who have received at least one prior therapy will receive Ixazomib in combination with lenalidomide and dexamethasone within the routine clinical practice in accordance with prescription. Duration of therapy - until disease progression or unacceptable toxicity.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with 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. | 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 | 
| Changes in symptom severity while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline | 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 | 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 | 
| Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone | 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 | Assessment will be done at 1, 3, 6, 9, 12 and 18 months after treatment with ixazomib in combination with lenalidomide and dexamethasone start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rates and duration of response to treatment with ixazomib in combination with lenalidomide and dexamethasone | Response to treatment will be assessed within the study and derived using the IMWG 2011 (International Myeloma Working Group). Duration of response will be evaluated from the time of initial response to treatment with ixazomib in combination with lenalidomide and dexamethasone till the disease progression or death from any cause | 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 | PFS will be estimated from initiation of treatment with ixazomib in combination with lenalidomide and dexamethasone till the disease progression or death from any cause. | 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 | OS will be estimated from initiation of treatment with ixazomib in combination with lenalidomide and dexamethasone till death from any cause | 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 | The analysis of safety of treatment with ixazomib in combination with lenalidomide and dexamethasone will include reporting adverse events (AEs)/serious AEs (SAEs). For adverse events assessment the NCI CTCAE v. 4.0 will be used. The incidence and severity of any AEs/SAEs will be evaluated within the study | 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life