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

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.

Study Overview

• Status: Unknown
• Conditions: Relapsed and/or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: ixazomib in combination with lenalidomide and dexamethasone

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: quality of life
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Lenalidomide; Ixazomib
• Other Study ID Numbers: IISR-2018-102607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No