Clinical trial NCT03903406: 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
Official title: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Relapsed and/or Refractory Multiple Myeloma
Keywords: quality of life
Lead sponsor: Multinational Center for Quality of Life Research, Russia
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with RRMM, who have received at least one prior therapy and who are suitable for triple therapy with ixazomib in combination with lenalidomide and dexamethasone. The eligibility criteria for this study are broader than the eligibility of patients to be treated with ixazomib in randomized clinical trials, so as to be reflective of routine clinical practice

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.


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.

Primary outcomes:
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
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
measure: Changes in number of satisfied/dissatisfied patients receiving ixazomib in combination with lenalidomide and dexamethasone
timeFrame: 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 outcomes:
measure: Overall response rates and duration of response to treatment with ixazomib in combination with lenalidomide and dexamethasone
timeFrame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
measure: Progression free survival (PFS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone
timeFrame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
measure: Overall survival (OS) in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone
timeFrame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
measure: Frequency of adverse events (AEs)/serious AEs in RRMM patients receiving ixazomib in combination with lenalidomide and dexamethasone
timeFrame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
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