Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001199707
Ethics application status
Approved
Date submitted
15/08/2022
Date registered
7/09/2022
Date last updated
3/10/2023
Date data sharing statement initially provided
7/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Using real-time feedback of patient-reported outcome measures to direct delivery of standard-of-care therapies in relapsed multiple myeloma
Scientific title
A parallel, non-blinded, multicentre, Bayesian randomised controlled trial to evaluate the effect of real-time feedback of patient reported outcome measures (PROMs) to treating clinicians on event free survival in patients with relapsed multiple myeloma (RMM).
Secondary ID [1] 307782 0
None
Universal Trial Number (UTN)
Trial acronym
MY-PROMPT-2
Linked study record
This record is a larger scale follow-on study based on the feasibility trial ACTRN12618001878268 which aimed to test the use or real-time reporting of PROMS to improve care in newly diagnosed multiple myeloma patients.

Health condition
Health condition(s) or problem(s) studied:
Relapsed Multiple Myeloma 327362 0
Condition category
Condition code
Cancer 324485 324485 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm:
Standard of Care (SoC) treatment plus real-time feedback of patient reported outcome measures (PROMs), including the MyPOS questionnaire and regimen specific questions, to clinicians.

Eligible SoC regimens are Lenalidomide (R), Carfilzomib (K) or Daratumumab (D) based regimens.

Participants will complete a multiple myeloma (MM)-specific PROM (MyPOS) within the week before each clinical visit using an online PROM collection system, which takes approximately 10 minutes to complete; completion in the clinic will also be possible if needed. Additional questions (no more than 5) will be added to ensure symptoms for common side effects of specific regimens (D or K based regimens) are covered, no more than 10 minutes to complete. Questionnaire access will be sent to participants via email each month, through a secure link. A summary of the completed MyPOS (plus/minus additional items) with results of concern only (set according to agreed parameters) and any free text will be provided to clinicians before clinical visits, to be incorporated in the patient’s care at their discretion. Questionnaire completion will be assessed by audit of the trial database. A reminder to complete the PROMS will be sent to participants the day before their visit, if not yet completed.

There will be a total of 13 standard of care visits over a 12 month period (day 1, months 1 to 12) where trial data will be collected, with the questionnaires being completed ahead of visits 13 times.
Intervention code [1] 324246 0
Treatment: Other
Comparator / control treatment
Control Arm:
SoC treatment alone

Participants will receive SoC treatment but will not complete PROMs for real-time feedback to clinician.
Control group
Active

Outcomes
Primary outcome [1] 332310 0
Event-free survival (EFS) is defined as the time from the date of randomisation to the date of permanent discontinuation of treatment, progression or death (whichever event comes first). Permanent discontinuation of treatment is permanent cessation of myeloma treatment, switching to an alternative therapy without progression will not be regarded as a failure event. Progression will be measured according to monthly standard of care (SoC) response reports per International Myeloma Working Group (IMWG) Uniform Response Criteria. Death is defined as date of death. When the study ends, participants not known to have discontinued treatment or not known to have progressed or died, will have their EFS censored at the date of their last visit which included both a review of therapy and an assessment of response status. Treatment review and response will be collected at monthly visits during the trial period and then 3 monthly during event-free survival follow-up (EFSF).
Timepoint [1] 332310 0
The primary timepoint is 42 months after first patient, first visit. The trial period for each participant lasts for 12 months from randomisation. Event-free Survival Follow-up (EFSF) commences at month 15 for each participant and continues until the primary timepoint is reached. Therefore, participation time in EFSF will vary for each participant. EFSF is conducted by medical chart review and does not require that participants attend trial visits.
Secondary outcome [1] 412959 0
Duration on therapy (DoT): time from commencement to permanent discontinuation of treatment regimen. Review of therapy will occur at monthly visits during the trial period and then by medical chart review every 3 months during EFSF.
Timepoint [1] 412959 0
The timepoint is 42 months after first patient, first visit. The trial period for each participant lasts for 12 months from randomisation. Event-free Survival Follow-up (EFSF) commences at month 15 for each participant and continues until the primary endpoint is reached. Therefore, participation time in EFSF will vary for each participant. EFSF is conducted by medical chart review and does not require that participants attend trial visits.
Secondary outcome [2] 412960 0
Health-related QOL: EORTC QLQ-C30 - includes cancer-specific symptoms and domains of function – collected three-monthly in all patients (intervention and controls) until Month 12.
Timepoint [2] 412960 0
At months 3, 6, 9 and 12 of the participant's trial period
Secondary outcome [3] 412961 0
Satisfaction with treatment: Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) – assesses satisfaction with treatment in pill or intravenous form - collected three-monthly in all patients.
Timepoint [3] 412961 0
At months 3, 6, 9 and 12 of the participant's trial period
Secondary outcome [4] 412962 0
Progression-free survival (PFS) is defined as the time from the date of randomisation to the date of progression or death (whichever event comes first). Progression will be measured according to monthly SoC response reports per IMWG Uniform Response Criteria during the trial period, then 3 monthly during EFSF. PFS When the study ends, patients not known to have progressed or died will have their PFS censored at the date of their last visit which included a response assessment and was prior to any subsequent anticancer therapy.
Timepoint [4] 412962 0
The timepoint is 42 months after first patient, first visit. The trial period for each participant lasts for 12 months from randomisation. Event-free Survival Follow-up (EFSF) commences at month 15 for each participant and continues until the primary endpoint is reached. Therefore, participation time in EFSF will vary for each participant. EFSF is conducted by medical chart review and does not require that participants attend trial visits.
Secondary outcome [5] 412963 0
Overall survival (OS) is defined as the time from the date of randomisation to the date of death. When the study ends, patients not known to have died will have their OS censored at the date of last contact regardless of any subsequent anticancer therapy. OS will be assessed at monthly reviews during the trial period and then every 3 months during EFSF by medical chart review.
Timepoint [5] 412963 0
The timepoint is 42 months after first patient, first visit. The trial period for each participant lasts for 12 months from randomisation. Event-free Survival Follow-up (EFSF) commences at month 15 for each participant and continues until the primary endpoint is reached. Therefore, participation time in EFSF will vary for each participant. EFSF is conducted by medical chart review and does not require that participants attend trial visits.
Secondary outcome [6] 412964 0
Overall Response (OR) (achievement of a partial response (PR) or better) defined using IMWG uniform response criteria and assessed as part of SoC. Response will be collected monthly during the trial period.
Timepoint [6] 412964 0
Response assessment reported at monthly visits until month 12 of the participants trial period will be used to determine OR.
Secondary outcome [7] 412965 0
ED visits: Number of ED presentations by participant report and review of medical records.
Timepoint [7] 412965 0
At month 12 of the participant's trial period
Secondary outcome [8] 412966 0
Hospital admissions: a composite secondary outcome, defined as the number of admissions and the number of days in hospital will be collected by patient report and review of medical records from the date of randomisation to the date of the last visit on study during the trial period.
Timepoint [8] 412966 0
At month 12 of the participant's trial period
Secondary outcome [9] 412967 0
Common non-haematologic adverse events (count and grade 1-4): peripheral sensory neuropathy, diarrhoea, upper respiratory tract infection, cough, fatigue, constipation, back pain, dyspnoea, fever, insomnia, pneumonia, hypertension - recorded in the medical record, either patient reported or as lab reports, and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE5.0)
Timepoint [9] 412967 0
At month 12 of the participant's trial period
Secondary outcome [10] 412968 0
Common haematologic adverse events (count and grade 1-4): Thrombocytopenia, anaemia, neutropenia, lymphopenia - recorded in the medical record with supporting lab reports, and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE5.0)
Timepoint [10] 412968 0
At month 12 of the participant's trial period

Eligibility
Key inclusion criteria
Patients are eligible for this trial if:
1. Aged equal to or more than 18 years of age
2. Diagnosis of RMM
3. Patients must be commencing a D, R or K based treatment, eligible for PBS reimbursement, as a second or later line of treatment
4. Patient must be consented to and registered on the Myeloma and Related Diseases Registry (MRDR)
5. Life expectancy > 12 months
6. Able to give informed consent for the trial, and willing and able to comply with each of the trial arms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for this trial if they fulfil any of the following criteria:
1. Patients who would not be able to complete the questionnaires for any reason
2. Treating team deems enrolment in the study is not in the best interests of the patient
3. Previous participation in this trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central computerised randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2023
Actual
13/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 25680 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 25681 0
The Alfred - Melbourne
Recruitment hospital [3] 25682 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 25683 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 41505 0
2050 - Camperdown
Recruitment postcode(s) [2] 41506 0
3004 - Melbourne
Recruitment postcode(s) [3] 41507 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 41508 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 312053 0
Government body
Name [1] 312053 0
National Health and Medical Research Council (NHMRC) – Medical Research Future Fund (MRFF) Grant
Country [1] 312053 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 313558 0
Other Collaborative groups
Name [1] 313558 0
Australasian Myeloma Research Consortium (AMaRC)
Address [1] 313558 0
Malignant Haematology & Stem Cell Transplantation Service
Level 2, South Block
Alfred Health
55 Commercial Road
Melbourne VIC 3004
Country [1] 313558 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311465 0
Monash Health HREC
Ethics committee address [1] 311465 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 311465 0
Australia
Date submitted for ethics approval [1] 311465 0
23/08/2022
Approval date [1] 311465 0
18/10/2022
Ethics approval number [1] 311465 0
RES-22-0000-520A

Summary
Brief summary
The aim of this study is to determine whether real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians improves duration on treatment in patients with relapsed multiple myeloma receiving standard of care treatment, when compared to standard of care treatment alone.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, have a diagnosis of relapsed multiple myeloma, and are commencing a lenalidomide, carfilzomib, or daratumumab based treatment regimen.

Study details
Participants will be randomised (i.e. allocated by chance) to receive standard of care treatment plus real-time feedback of PROMs, or to receive standard of care treatment alone. Participants in the intervention group will be asked to complete a multiple myeloma-specific quality of life questionnaire (myPOS) within the week before each clinical visit using an online PROM collection system. Participants receiving daratumumab or carfilzomib based regimens will also complete additional questions regarding treatment-specific side effects at this time. The questionnaires will take approximately 10 minutes to complete, and will be completed prior to a total of 13 visits over a period of 12 months. A summary of the completed questionnaires with results of concern will be provided to your treating clinician before clinical visits, so that the results may be considered in your care. Participants in the standard of care alone group will not complete the MyPOS questionnaire prior to clinic visits. All participants will be asked to complete a quality of life questionnaire and a treatment satisfaction questionnaire every three months. Participants in the standard of care alone group, receiving daratumumab or carfilzomib based regimens, will also be asked to complete the additional questions regarding treatment-specific side effects every 3 months. After a period of 12 months, all participants will have data collected from their medical records on time to discontinuation of treatment, disease progression, and survival, and will complete questionnaires regarding quality of life, side effects, and treatment satisfaction.

It is hoped that this study may show that real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians at clinic visits improves duration on treatment and survival when compared to patients on standard of care alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121190 0
Prof Andrew Spencer
Address 121190 0
Malignant Haematology & Stem Cell Transplantation Service
Level 2, South Block
Alfred Health
55 Commercial Road
Melbourne VIC 3004
Country 121190 0
Australia
Phone 121190 0
+61 03 90763451
Fax 121190 0
Email 121190 0
[email protected]
Contact person for public queries
Name 121191 0
Ms Tina van Tonder
Address 121191 0
Monash University
553 St Kilda Road
Melbourne
Victoria
3004
Country 121191 0
Australia
Phone 121191 0
+61 1800 811 326
Fax 121191 0
Email 121191 0
[email protected]
Contact person for scientific queries
Name 121192 0
Ms Tina van Tonder
Address 121192 0
Monash University
553 St Kilda Road
Melbourne
Victoria
3004
Country 121192 0
Australia
Phone 121192 0
+61 1800 811 326
Fax 121192 0
Email 121192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data privacy regulations


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.