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: Relapsed and/or Refractory Multiple Myeloma

• Registration Number: NCT03903406
• Lead Sponsor: Multinational Center for Quality of Life Research, Russia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-04
• Last Update Posted: 2019-04-04
• Study Start: 2019-05
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with 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	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	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	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 Outcome Measures

Name	Time	Method
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	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
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	OS will be estimated from initiation of treatment with ixazomib in combination with lenalidomide and dexamethasone till death from any cause
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	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
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	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.