Relapsed and/or Refractory Multiple MyelomaNCT03903406
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
An observational study of Relapsed and/or Refractory Multiple Myeloma, run by Multinational Center for Quality of Life Research, Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- ixazomib in combination with lenalidomide and dexamethasone
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients currently enrolled in any other clinical trials
- Patients with contraindications to ixazomib in accordance with instruction for use.
Trial locations and contacts
No sites are listed yet.
About this 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.
- Being tested
- ixazomib in combination with lenalidomide and dexamethasone
- Keywords
- quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ixazomib in combination with lenalidomide and dexamethasoneDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study startMay 2019 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multinational Center for Quality of Life Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903406
- Sponsor's protocol ID
- IISR-2018-102607
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03903406
- Acronym / sponsor ID
- IISR-2018-102607
- Keywords
- quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Multinational Center for Quality of Life Research, RussiaUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients currently enrolled in any other clinical trials
- Patients with contraindications to ixazomib in accordance with instruction for use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ixazomib in combination with lenalidomide and dexamethasonePatients 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. | Drug | – |
Primary outcome
Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline
Time frame: 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
Time frame: 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
Time frame: 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
4 secondary outcomes
Overall response rates and duration of response to treatment with ixazomib in combination with lenalidomide and dexamethasone
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 18 mos from the start of treatment with ixazomib in combination with lenalidomide and dexamethasone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed and/or Refractory Multiple Myeloma, run by Multinational Center for Quality of Life Research, Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Nikitina, PhD (+79627101712, tnikitina_74@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Сhanges in quality of life (QoL) while treatment with ixazomib in combination with lenalidomide and dexamethasone as compared with baseline (time frame: 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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.