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

NCT03903406 | Unknown

• 1 other identifier: IISR-2018-102607
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsed and/or Refractory Multiple Myeloma

Keywords

quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• 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

• 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

Interventions

ixazomib in combination with lenalidomide and dexamethasone DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients currently enrolled in any other clinical trials
• Patients with contraindications to ixazomib in accordance with instruction for use.

Sponsors & Collaborators

• Multinational Center for Quality of Life Research, Russia: lead

MeSH Terms

Interventions

ixazomib; Lenalidomide; Dexamethasone

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Tatiana Nikitina, PhD

CONTACT

+79627101712; tnikitina_74@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: May 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share