Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001308785
Ethics application status
Approved
Date submitted
8/08/2022
Date registered
10/10/2022
Date last updated
17/04/2024
Date data sharing statement initially provided
10/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ALLG MM26/NORM: Novel Combinations for Orphan Myeloma: The NORM platform study Master Protocol
Scientific title
ALLG MM26/NORM: Novel Combinations for Orphan Myeloma: The NORM platform study Master Protocol
Secondary ID [1] 307479 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ALLG: MM26/NORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
relapsed/refractory multiple myeloma 326872 0
Condition category
Condition code
Cancer 324082 324082 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be a platform trial evaluating patients with relapsed/refractory
(R/R) multiple myeloma with different drug combinations in different patient
strata:
Stratum A: Renal impairment (Creatinine Clearance less than 30ml/min)
Stratum B: Non-measurable disease
Stratum C: Extramedullary plasmacytomas
Stratum D: Central Nervous System involvement

Procedures for relevant treatment domains will be found in the relevant appendix to this master protocol. The participants will complete the following activities prior to being allocated to a specific treatment domain:
1. Participant diagnosed with relapsed/refractory multiple myeloma.
2. Participant will sign a master screening consent form and entered into a database and registered. Participants will be screened prior to being allocated to a stratum. Participants will undergo undergo blood, urine, CT (Neck/chest/abdomen/pelvis), CT skeletal survey, PET and MRI Brain prior to entering the study to ensure all eligibility criteria are met.
3.Strata allocation (trial registration number allocated) based on the abovementioned stratums A to D.
4. Once Strata allocation identified, participant will be consented to available treatment domain
5. Participant will be undergo screening procedures for that specific domain study.
6.Treatment domain allocated to participant.

Therapies within the domain studies will consist of a combination of chemotherapy and targeted biological therapies.

Treatment domains may involve a single treatment, or multiple treatments to be trialled. For those domains with multiple treatments, participants may be randomised to one of the available treatments once they have been allocated to that domain.

Duration of this platform trial will depend on the treatment domain (eg. Total trial duration for domain 1 is three years). There is no minimum or maximum number of cycles of treatment and study treatment will continue until the participant experiences either unacceptable toxicity, or disease progression.
Intervention code [1] 323932 0
Treatment: Drugs
Comparator / control treatment
'No control group"
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331882 0
To determine the efficacy of a specified novel agent 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 [1] 331882 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response assessments are to be completed on or before Cycle 5 Day 1 except in the case of Positron emission tomography (PET) or Computerised tomography (CT), CT and Magnetic resonance imaging (MRI) scans which can be completed up to 2 weeks after 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 [2] 332239 0
To determine the efficacy of a specified novel agent 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 [2] 332239 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response assessments are to be completed on or before Cycle 5 Day 1 except in the case of Positron emission tomography (PET) or Computerised tomography (CT), CT and Magnetic resonance imaging (MRI) scans which can be completed up to 2 weeks after 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] 332240 0
To determine the efficacy of a specified novel agent in each of four strata of orphan myeloma in the first 4 cycles of therapy.

Stratum C: Refers to patients with extramedullary plasmacytomas.
Timepoint [3] 332240 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4.

Response assessments are to be completed on or before Cycle 5 Day 1 except in the case of Positron emission tomography (PET) or Computerised tomography (CT), CT and Magnetic resonance imaging (MRI) scans which can be completed up to 2 weeks after the end of Cycle 4.

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.
Secondary outcome [1] 411988 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 [1] 411988 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 stopped due to the participant 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 [2] 412002 0
To investigate the kinetics of response to a novel agent in each of four strata of orphan myeloma in the first 12 cycles of therapy.
Timepoint [2] 412002 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] 412003 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 [3] 412003 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 [4] 412004 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 [4] 412004 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 [5] 412005 0
Safety: To characterize the safety and tolerability of novel agents in each of the four strata of orphan myeloma.
Timepoint [5] 412005 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 [6] 412006 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 [6] 412006 0
Quality of Life (QoL) measured using EORTC QLQ-C30 and QLQ-MY20 on Day 1 of each cycle and at the end of treatment. Patients reach EOT when study treatment is stopped due to the participant experiencing either unacceptable toxicity, or disease progression.
Secondary outcome [7] 413454 0
Please note this outcome is a primary outcome:

To determine the efficacy of a specified novel agent 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 [7] 413454 0
Achievement of a partial response (PR) or better at any time up to the end of cycle 4 (within 1 week of the end of each cycle).

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 disease): must also meet all the following criteria: no new sites of disease, greater than or equal to 50% decrease in the contrast-enhancing lesion seen on MRI compared with baseline, and a decrease in the vitreous cell count or retinal/optic nerve cellular infiltrate. Cerebrospinal fluid (CSF) cytology may continue to show persistent malignant or suspicious cells.

Eligibility
Key inclusion criteria
All of the following criteria must be satisfied for enrolment in the trial. The domain specific appendix can refine the inclusion and exclusion criteria in this Master Protocol.

1. Histologically confirmed diagnosis of symptomatic multiple myeloma as per IMWG
2. Relapsed or refractory multiple myeloma with documented evidence of progressive disease (PD) following at least 1 prior line of therapy
3 .Must met one of the following criteria
• Renal impairment, defined as Cockcroft-Gault, CrCl less than 30ml/min (stratum A)
• Non-measurable disease, defined as a paraprotein less than 5g/L on serum EPG/IFE, involved light chain less than 100mg/L and urinary Bence Jones protein less than 200mg/L (stratum B)
• Extramedullary plasmacytoma (stratum C)
• CNS myeloma (stratum D)
4. Has provided written informed consent
5. Available for follow-up for 3 years
6 .Females of childbearing potential must use an effective method of contraception or practice absolute abstinence as required for individual drug combinations (see relevant appendices)
7. Male patients must use contraception measures as required for individual drug combinations (see relevant appendices)
8 .For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
9. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
10. An ECOG performance status score of 2 or less at Screening
11. Subjects must agree not to share their medication and to return unused supplies
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of any of the following criteria will exclude the subject from enrolment in the trial. The domain specific appendix can refine the inclusion and exclusion criteria in this Master Protocol.

1. Women who are pregnant or lactating.
2. Patients who have had investigational anti-cancer therapy, chemotherapy or radiotherapy within 4 weeks of Cycle 1 Day 1
3. Prior diagnosis of cancer that was:
• more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
• within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
4. Documented systemic amyloid light chain amyloidosis
5. Red blood cell or platelet transfusion within 14 days of screening
6. Patients with uncontrolled intercurrent illness, e.g. uncontrolled active hypertension or diabetes.
7. Active, unstable cardiovascular function:
a. Symptomatic ischemia
b. Uncontrolled, clinically-significant conduction abnormalities (patients with ventricular tachycardia on antiarrhythmics are excluded, patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded) or
c. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class greater than or equal to 3, or
d. Myocardial infarction (MI) within 3 months prior to C1D1
e. Ejection fraction (EF) less than 50% at screening
8. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
9. Known HIV infection
10. Patients with psychiatric illness/social situations that would limit compliance with trial requirements.
11. Has any other clinically important abnormalities as determined by the investigator that may interfere with participation in or compliance with the trial.
12. Presence of any psychological, familial or sociological condition potentially hampering compliance with the trial protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.

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 trial will be a platform trial evaluating patients with relapsed/refractory multiple myeloma with different drug combinations in different patient stratum:
• 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For each domain and for each activated stratum within a domain, and unless
otherwise stated in the relevant domain-specific appendix, a dual-criteria
Bayesian proof-of-concept approach will be used to monitor and report on the
efficacy for each stratum (Neuenschwander, 2011; Sverdlov 2015).

Proof-of-concept (PoC) for the efficacy of the treatment will be claimed if two
criteria are met: a pre-determined overall response rate and a pre-determined
futility rate. The nominated thresholds for the rates and the required level of
proof will be documented for each treatment domain in the relevant domain specific appendix.

We will begin monitoring the primary endpoint in each stratum after a specific
number of patients have completed 4 cycles (or have withdrawn). Operating
characteristics for the proof-of-concept approach in a stratum will be determined by simulation once the thresholds are established; these will be documented for each treatment domain in the relevant appendix.

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
70
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24904 0
New Zealand
State/province [1] 24904 0

Funding & Sponsors
Funding source category [1] 311757 0
Other Collaborative groups
Name [1] 311757 0
Australasian Leukaemia & Lymphoma Group
Country [1] 311757 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] 313368 0
None
Name [1] 313368 0
Address [1] 313368 0
Country [1] 313368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311200 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 311200 0
Ethics committee country [1] 311200 0
Australia
Date submitted for ethics approval [1] 311200 0
14/11/2022
Approval date [1] 311200 0
27/02/2023
Ethics approval number [1] 311200 0

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

Contacts
Principal investigator
Name 120302 0
Prof Hang Quach
Address 120302 0
Department of Haematology, St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy , VIC 3065.
Country 120302 0
Australia
Phone 120302 0
+61 3 92312030
Fax 120302 0
Email 120302 0
[email protected]
Contact person for public queries
Name 120303 0
Delaine Smith
Address 120303 0
Australasian Leukaemia and Lymphoma Group
Ground Floor, 35 Elizabeth Street,
Richmond
VIC 3121
Country 120303 0
Australia
Phone 120303 0
+61 3 8373 9701
Fax 120303 0
Email 120303 0
[email protected]
Contact person for scientific queries
Name 120304 0
Delaine Smith
Address 120304 0
Australasian Leukaemia and Lymphoma Group
Ground Floor, 35 Elizabeth Street,
Richmond
VIC 3121
Country 120304 0
Australia
Phone 120304 0
+61 3 8373 9701
Fax 120304 0
Email 120304 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
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.