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

NCT ID: NCT03903406

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-31

Study Completion Date

2021-11-30

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.

Detailed Description

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Conditions

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Relapsed and/or Refractory Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Multinational Center for Quality of Life Research, Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Tatiana Nikitina, PhD

Role: CONTACT

+79627101712

Other Identifiers

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IISR-2018-102607

Identifier Type: -

Identifier Source: org_study_id

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