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Trial registered on ANZCTR


Registration number
ACTRN12622001313729
Ethics application status
Approved
Date submitted
30/08/2022
Date registered
11/10/2022
Date last updated
23/02/2024
Date data sharing statement initially provided
11/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ALLG MM26/D1: Novel Combinations for Orphan Myeloma: The NORM Platform study: Treatment Specific Appendix - Selinexor, Pomalidomide, Dexamethasone (SPd)
Scientific title
ALLG MM26/D1: Novel Combinations for Orphan Myeloma: The NORM Platform study: Treatment Specific Appendix: Selinexor, Pomalidomide, Dexamethasone (SPd)
Secondary ID [1] 307759 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
NORM:SPd
Linked study record
This study is the first domain of the MM26 NORM platform trial (Master Protocol registered under ACTRN12622001308785).

Health condition
Health condition(s) or problem(s) studied:
Relapsed/ Refractory Multiple Myeloma 327332 0
Condition category
Condition code
Cancer 324464 324464 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MM26/D1 is domain 1 of the MM26 NORM Platform trial. This domain will determine the safety and efficacy of Selinexor, Pomalidomide and Dexamethasone in treating patients who have had at least one relapse or refractory multiple myeloma. Participants meeting inclusion for MM26 Master Protocol in Strata A (renal impairment), B (non-measurable disease), C (extramedullary plasmacytoma), or D (CNS myeloma) will be considered for Domain 1, after undergoing separate screening procedures

For participants with renal impairment (Strata A) the study will be conducted in two stages.
Stage 1: A safety run-in stage will confirm the planned optimal dose schedule for these participants. Up to 10 participants will be enrolled in a lead-in safety phase and monitored by the Trial Monitoring Committee (TMC) for treatment related toxicities.
If the initial dose level of Pomalidomide and Selinexor is deemed intolerable, other dose levels will be explored. Decisions to escalate or de-escalate the dose and the identification of the optimal dose will be guided by use of a dual-criteria Bayesian proof-of-concept approach.
If more than 3 of the first 10 evaluable participants have grade 4 related non-haematological toxicity, then the causative agent (pomalidomide or Selinexor) will be determined by the TMC, and a dose reduction instituted as per dose levels described below.
Each treatment cycle will be 28 days for the first two cycles only.
The dose de-escalation schedule for Strata A is as follows:
Level 1 (starting dose):
Pomalidomide 4mg (oral) – Daily for days 1 to 21
Selinexor 60mg (oral) - weekly
Level 2:
Pomalidomide 3mg (oral) Daily for days 1 to 21
Selinexor 40mg (oral) - weekly
Level 3:
Pomalidomide 2mg (oral) Daily for days 1 to 21.
Selinexor 20mg (oral) - weekly

Stage 2: Provided that no more than 3 participants in the first 10 evaluable participants develop grade 4 treatment-related toxicities, the stratum will proceed to the expansion phase. Participants proceeding to the expansion phase will continue with treatment at the recommended dose determined in the lead-in phase. Expansion phase continues until the participant withdraws from disease progression or unacceptable toxicity.

For all other participants from Strata B (Non-measurable disease), Strata C (Extramedullary plasmacytomas) and Strata D (CNS involvement) the following study treatment will be assigned in a 28-day cycle:

Selinexor 60mg (oral) weekly
Pomalidomide 4mg on days 1 to 21 (oral)
Dexamethasone 40mg (oral) weekly (20mg if greater than 75 years old).

All participants enrolled to Domain 1 will continue study medication unless they develop disease progression, unacceptable treatment related toxicities, withdraw consent or are loss to follow-up.

Compliance will be monitored via drug accountability exercises completed by the participating site and the sponsor.
Intervention code [1] 324247 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332666 0
To determine the efficacy of treatment with Selinexor, Pomalidomide, Dexamethasone (SPd) in each of four strata of orphan myeloma in the first 4 cycles of therapy.

Stratum C: Refers to patients with extramedullary plasmacytomas.
Timepoint [1] 332666 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response rates are defined by the International Myeloma Working Group (IMWG) consensus criteria for response and minimal residual disease assessment in multiple myeloma. The following response rates are considered to be PR or better:

PR is defined in IMWG criteria as greater than or equal to 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by greater than or equal to 90 %or to less than 200 mg per 24 hours;
- If the serum and urine M-protein are unmeasurable, a greater than or equal to 50% decrease in the difference between involved and uninvolved Free Light Chain (FLC) levels is required in place of the M-protein criteria;
- If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, greater than or equal to 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was greater than or equal to 30%. In addition to these criteria, if present at baseline, a greater than or equal to 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required

Very good partial response (VGPR) is defined in IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 h.

Complete response (CR) is defined in IMWG criteria as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than 5% plasma cells in bone marrow aspirates.

Stringent complete response (sCR.) is defined in IMWG criteria as a complete response below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (kappa/lambda ratio less than or equal to 4:1 or greater than or equal to 1:2 for kappa and lambda patients, respectively, after counting greater than 100 plasma cells).

For Strata C (extramedullary plasmacytomas) the following also applies:
- In patients with BM plasma cell percentage greater than 30% and no extramedullary plasmacytomas: use IMWG criteria
- In patients with BM plasma cell percentage greater than 30% and extramedullary plasmacytomas: use IMWG criteria to assess both bone marrow response and response of extramedullary plasmacytomas.
- For patients with BM plasma cell percentage less than 30% and extramedullary plasmacytomas: use IMWG criteria for assessment of extramedullary
plasmacytomas.
- For patients with BM plasma cell percentage less than 30% and no extramedullary plasmacytomas: use PET assessment. Partial response defined as a partial metabolic response.
Primary outcome [2] 332345 0
To determine the efficacy of treatment with Selinexor, Pomalidomide, Dexamethasone (SPd) in each of four strata of orphan myeloma in the first 4 cycles of therapy.

Stratum A: refers to patients with renal impairment (creatinine clearance of less than 30mls per minute)
Timepoint [2] 332345 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response rates are defined by the International Myeloma Working Group (IMWG) consensus criteria for response and minimal residual disease assessment in multiple myeloma. The following response rates are considered to be PR or better:

PR is defined in IMWG criteria as greater than or equal to 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by greater than or equal to 90% or to less than 200 mg per 24 hours;
- If the serum and urine M-protein are unmeasurable, a greater than or equal to 50% decrease in the difference between involved and uninvolved Free Light Chain (FLC) levels is required in place of the M-protein criteria;
- If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, greater than or equal to 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was greater than or equal to 30%. In addition to these criteria, if present at baseline, a greater than or equal to 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required

Very good partial response (VGPR) is defined in IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 h.

Complete response (CR) is defined in IMWG criteria as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than 5% plasma cells in bone marrow aspirates.

Stringent complete response (sCR.) is defined in IMWG criteria as a complete response below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (kappa/lambda ratio less than or equal to 4:1 or greater than or equal to 1:2 for kappa and lambda patients, respectively, after counting greater than 100 plasma cells).
Primary outcome [3] 332665 0
To determine the efficacy of treatment with Selinexor, Pomalidomide, Dexamethasone (SPd) in each of four strata of orphan myeloma in the first 4 cycles of therapy.

Stratum B: refers to patients with non-measurable disease (paraprotein less than 10g/dl).
Timepoint [3] 332665 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response rates are defined by the International Myeloma Working Group (IMWG) consensus criteria for response and minimal residual disease assessment in multiple myeloma. The following response rates are considered to be PR or better:

PR is defined in IMWG criteria as greater than or equal to 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by greater than or equal to 90 %or to less than 200 mg per 24 hours;
- If the serum and urine M-protein are unmeasurable, a greater than or equal to 50% decrease in the difference between involved and uninvolved Free Light Chain (FLC) levels is required in place of the M-protein criteria;
- If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, greater than or equal to 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was greater than or equal to 30%. In addition to these criteria, if present at baseline, a greater than or equal to 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required

Very good partial response (VGPR) is defined in IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 h.

Complete response (CR) is defined in IMWG criteria as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than 5% plasma cells in bone marrow aspirates.

Stringent complete response (sCR.) is defined in IMWG criteria as a complete response below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (kappa/lambda ratio less than or equal to 4:1 or greater than or equal to 1:2 for kappa and lambda patients, respectively, after counting greater than 100 plasma cells).
Secondary outcome [1] 414325 0
To assess the effect of therapy with novel agent(s) on the Quality of Life of patients in the four strata of orphan myeloma.
Timepoint [1] 414325 0
Quality of Life (QoL) measured using EORTC QLQ-C30 and QLQ-MY20 on Day 1 of each cycle and at EOT. Patients reach EOT when study treatment is discontinued due to experiencing either unacceptable toxicity, or disease progression.
Secondary outcome [2] 414320 0
To investigate the kinetics of response to a novel agent in each of four strata of orphan myeloma in the first 12 months.
Timepoint [2] 414320 0
Response status (Death, Progressive disease (PD), Stable Disease (SD), Morphological Relapse (MR), Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR)) at the end of cycles 2, 4, 6 and 12. Response assessments are to be completed on or before Day 1 of the following cycle except in the case of PET/CT, CT and MRI scans which can be completed up to 2 weeks after the end of the cycle.
Secondary outcome [3] 413108 0
Please note this is a Primary Outcome [4]:

To determine the efficacy of treatment with Selinexor, Pomalidomide, Dexamethasone (SPd) in each of four strata of orphan myeloma in the first 4 cycles of therapy.

Stratum D: Refers to patients with central nervous system involvement.
Timepoint [3] 413108 0

Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response rates are defined by the International Myeloma Working Group (IMWG) consensus criteria for response and minimal residual disease assessment in multiple myeloma. The following response rates are considered to be PR or better:

PR is defined in IMWG criteria as greater than or equal to 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by greater than or equal to 90 %or to less than 200 mg per 24 hours;
- If the serum and urine M-protein are unmeasurable, a greater than or equal to 50% decrease in the difference between involved and uninvolved Free Light Chain (FLC) levels is required in place of the M-protein criteria;
- If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, greater than or equal to 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was greater than or equal to 30%. In addition to these criteria, if present at baseline, a greater than or equal to 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required

Very good partial response (VGPR) is defined in IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 h.

Complete response (CR) is defined in IMWG criteria as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than 5% plasma cells in bone marrow aspirates.

Stringent complete response (sCR.) is defined in IMWG criteria as a complete response below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (kappa/lambda ratio less than or equal to 4:1 or greater than or equal to 1:2 for kappa and lambda patients, respectively, after counting greater than 100 plasma cells).

For stratum D (CNS myeloma), the following additional criteria must be met:
(i) no new sites of disease,
(ii) 50% decrease in the contrast-enhancing lesion seen on MRI compared with baseline, and
(iii) a decrease in the vitreous cell count or retinal/optic nerve cellular infiltrate. CSF cytology may continue to show persistent malignant or suspicious cells.
Secondary outcome [4] 414321 0
To determine durability of progression-free response status in patients treated with a specified novel agent in each of four strata of orphan myeloma.
Timepoint [4] 414321 0
Progression-free survival (PFS): Measured from the date of randomisation (or registration if the domain has a single arm) to the earlier of the date of progression or death from any cause.
Secondary outcome [5] 414323 0
To determine durability of event-free status in patients treated with a specified novel agent in each of four strata of orphan myeloma.
Timepoint [5] 414323 0
Event-free survival (EFS): Measured from the date of commencement of treatment on study (Cycle 1 Day 1) to the earliest date of these events: date off protocol treatment for any reason (except completion of protocol-specified treatment duration) the date of progression or the date of death from any cause. This data will obtained from source medical data e.g. medical records.
Secondary outcome [6] 414324 0
Safety: To characterize the safety and tolerability of novel agents in each of the four strata of orphan myeloma.
Timepoint [6] 414324 0
Occurrence of newly occurring or worsening …
Related CTCAEv5 grade 3-5 non-hematologic adverse events (AEs).
Related CTCAE grade 4-5 neutropenia or thrombocytopenia or grade 3-5 febrile neutropenia in each of the first 4 cycles of therapy. For combination therapies, "relatedness" refers to any agent in the combination. Grade is the worst grade recorded in the cycle, AEs will be reported by participants at any time from the date of commencement of treatment on study (Cycle 1 Day 1) until treatment cessation or death from any cause,
Secondary outcome [7] 414319 0
To determine the efficacy of a specified novel agent in each of four strata of orphan myeloma at any time on protocol-specified therapy.
Timepoint [7] 414319 0
Best response (IMWG defined response) at any time on protocol-specified therapy with the novel agent. Response assessments are to be completed on or before the last date of protocol-specified therapy except in the case of PET/CT, CT and MRI scans which can be completed up to 2 weeks after the end of protocol therapy. These assessments can be carried out within 1 week of the end cycle 4, 8, 12, 16 and every 4 cycles until EOT. Patients reach EOT when study treatment is discontinued due to experiencing either unacceptable toxicity, or disease progression.

Response rates are defined by the International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. The following response rates are considered to be PR or better:

PR is defined in IMWG criteria as greater than or equal to 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by greater than or equal to 90% or to less than 200 mg per 24 h;
If the serum and urine M-protein are unmeasurable, a greater than or equal to 50% decrease in the difference between involved and uninvolved Free Light Chain (FLC) levels is required in place of the M-protein criteria;
If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, greater than or equal to 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was greater than or equal to 30%. In addition to these criteria, if present at baseline, a greater than or equal to 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required

Very good partial response (VGPR) is defined in IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 h.

Complete response (CR) is defined in IMWG criteria as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than 5% plasma cells in bone marrow aspirates.

Stringent complete response (sCR.) is defined in IMWG criteria as a complete response below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (kappa/lambda ratio less than or equal to 4:1 or greater than or equal to 1:2 for kappa and lambda patients, respectively, after counting greater than 100 plasma cells).
Secondary outcome [8] 414322 0
To determine the survival of patients treated with a specified novel agent in each of four strata of orphan myeloma.
Timepoint [8] 414322 0
Overall survival (OS): Measured from the date of randomisation (or registration if the domain has a single arm) to the date of progression or death from any cause.

Eligibility
Key inclusion criteria
Eligibility criteria specific to Treatment Specific Appendix - Selinexor, Pomalidomide, Dexamethasone (SPd) include:
1.Previous bortezomib therapy and either: failure to achieve at least a partial response (PR) during treatment OR progressive disease (PD) during treatment or within 6 months of discontinuing treatment OR contraindication or experienced an intolerance to treatment with bortezomib AND
2.Previous lenalidomide therapy and either: treatment failure with lenalidomide, as confirmed by progressive disease during treatment within 6 months of discontinuing lenalidomide OR a contraindication or intolerance to treatment with lenalidomide.
3.Must agree to contraceptive requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
See ALLG MM26/NORM: Novel Combinations for Orphan Myeloma: The NORM platform study Master Protocol for eligibility criteria relevant to all domain protocols.

Exclusion criteria specific to Treatment Specific Appendix - Selinexor, Pomalidomide, Dexamethasone (SPd) include:
1.Previous treatment with pomalidomide or Selinexor
2.Contraindication to pomalidomide, Selinexor or dexamethasone
3.Active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of trial treatments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Other design features
This study will enrol participants into different strata depending on their disease characteristics:
• Stratum A: Renal impairment (Creatinine Clearance less than 30ml per minute)
• Stratum B: Non-measurable disease
• Stratum C: Extramedullary plasmacytomas
• Stratum D: Central nervous system involvement
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For each stratum, 95% credible intervals for the overall response rate (ORR) will be calculated and will utilise a minimally informative prior for the rate. A dual-criteria Bayesian proof-of-concept approach will be used to monitor and statistically analyse each stratum. Proof-of-concept (PoC) for the efficacy of the treatment in a stratum will be claimed if two criteria are met:

Stratum A or B:
(i) Observed overall response rate greater than or equal to 40%.
(ii) Posterior probability that the true response rate is greater than or equal to 30% (the futility rate), given the data, is greater than or equal to 0.90 (the level of proof).

Stratum C or D:
(i) Observed overall response rate greater than or equal to 30%.
(ii) Posterior probability that the true response rate is greater than or equal to 20% (the futility rate), given the data is greater than or equal to 0.90 (the level of proof).


40 patients will be recruited in each of strata A, B and C, but accrual to a stratum may be terminated early for proof of concept or for futility.

Monitoring the primary endpoint in each stratum will commence when at least 12 to 20 patients have completed 4 cycles (or have withdrawn).


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2023
Actual
2/08/2023
Date of last participant enrolment
Anticipated
19/01/2025
Actual
Date of last data collection
Anticipated
19/01/2027
Actual
Sample size
Target
140
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24962 0
New Zealand
State/province [1] 24962 0
Country [2] 26176 0
Korea, Democratic People's Republic Of
State/province [2] 26176 0
Gyeonggi-do
Country [3] 26169 0
China
State/province [3] 26169 0
Shanghai
Country [4] 26172 0
Korea, Democratic People's Republic Of
State/province [4] 26172 0
Seoul
Country [5] 26170 0
China
State/province [5] 26170 0
Beijing
Country [6] 26168 0
Taiwan, Province Of China
State/province [6] 26168 0
Taibei
Country [7] 26175 0
Korea, Democratic People's Republic Of
State/province [7] 26175 0
Busan
Country [8] 26167 0
Singapore
State/province [8] 26167 0
Singapore
Country [9] 26174 0
Korea, Democratic People's Republic Of
State/province [9] 26174 0
South Gyeongsang
Country [10] 26171 0
Hong Kong
State/province [10] 26171 0
Hong Kong
Country [11] 26173 0
Korea, Democratic People's Republic Of
State/province [11] 26173 0
Gwangju

Funding & Sponsors
Funding source category [1] 312024 0
Other Collaborative groups
Name [1] 312024 0
Australasian Leukaemia & Lymphoma Group
Country [1] 312024 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia & Lymphoma Group
Address
Ground Floor, 35 Elizabeth St, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 313525 0
None
Name [1] 313525 0
Address [1] 313525 0
Country [1] 313525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311444 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 311444 0
Ethics committee country [1] 311444 0
Australia
Date submitted for ethics approval [1] 311444 0
14/11/2022
Approval date [1] 311444 0
27/02/2023
Ethics approval number [1] 311444 0
2022/PID06553

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121114 0
Prof Hang Quach
Address 121114 0
Department of Haematology, St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy , VIC 3065.
Country 121114 0
Australia
Phone 121114 0
+61 3 92312030
Fax 121114 0
Email 121114 0
Hang.Quach@svha.org.au
Contact person for public queries
Name 121115 0
Delaine Smith
Address 121115 0
Australasian Leukaemia and Lymphoma Group
Ground Floor, 35 Elizabeth Street,
Richmond
VIC 3121
Country 121115 0
Australia
Phone 121115 0
+61 3 8373 9701
Fax 121115 0
Email 121115 0
delaine.smith@allg.org.au
Contact person for scientific queries
Name 121116 0
Delaine Smith
Address 121116 0
Australasian Leukaemia and Lymphoma Group
Ground Floor, 35 Elizabeth Street,
Richmond
VIC 3121
Country 121116 0
Australia
Phone 121116 0
+61 3 8373 9701
Fax 121116 0
Email 121116 0
delaine.smith@allg.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be shared publicly. Aggregate patient data and final results will be presented in the final report.


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.