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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05259839
Registration number
NCT05259839
Ethics application status
Date submitted
18/02/2022
Date registered
2/03/2022
Titles & IDs
Public title
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
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Scientific title
A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
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Secondary ID [1]
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2021-005587-22
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Secondary ID [2]
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M22-947
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-383
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Nirogacestat
Treatment: Drugs - Daratumumab
Experimental: Arm A (ABBV-383 with Pomalidomide and Dexamethasone) - Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.
Experimental: Arm B (ABBV-383 with Lenalidomide and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.
Experimental: Arm C (ABBV-383 with Daratumumab and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.
Experimental: Arm D (ABBV-383 with Nirogacestat) - Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.
Treatment: Drugs: ABBV-383
Intravenous (IV) Infusion
Treatment: Drugs: Dexamethasone
Oral; Tablet or IV Infusion
Treatment: Drugs: Lenalidomide
Oral; Capsule
Treatment: Drugs: Pomalidomide
Oral; Capsule
Treatment: Drugs: Nirogacestat
Oral; Tablet
Treatment: Drugs: Daratumumab
Subcutaneous Injection (SC)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383
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Assessment method [1]
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DLT events as described in the protocol will be assessed.
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Timepoint [1]
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Up to approximately 28 Days
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Primary outcome [2]
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Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
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Timepoint [2]
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Up to Approximately 3 Years
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as partial response(PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
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Timepoint [1]
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Up to Approximately 3 Years
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Secondary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
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Timepoint [2]
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Up to Approximately 3 Years
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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DOR will be defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.
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Timepoint [3]
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Up to Approximately 3 Years
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Secondary outcome [4]
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Time-to-Progression (TTP)
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Assessment method [4]
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TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
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Timepoint [4]
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Up to Approximately 3 Years
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Secondary outcome [5]
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Percentage of Participants with Minimal Residual Disease Negativity (MRD)
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Assessment method [5]
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MRD is defined as the percentage of participants with assessment of the minimal residual disease.
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Timepoint [5]
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Up to Approximately 3 Years
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
* Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
* Must have measurable disease as outlined in the protocol.
* Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
* Has received prior MM treatment in Arms A, B, C, and D.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment.
* Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
* Known central nervous system involvement Multiple Myeloma (MM).
* Has any of the following conditions:
* Nonsecretory MM.
* Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
* Waldenstrom's macroglobulinemia.
* Light chain amyloidosis.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
* Major surgery within 4 weeks prior to first dose or planned study participation.
* Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral).
* Uncontrolled diabetes or hypertension within 14 days prior to first dose.
* Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
* Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/07/2031
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Actual
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Sample size
Target
270
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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St George Hospital /ID# 243740 - Kogarah
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Recruitment hospital [2]
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Calvary Mater Newcastle /ID# 243730 - Waratah
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Monash Medical Centre /ID# 244403 - Clayton
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St Vincent's Hospital Melbourne /ID# 256879 - Fitzroy Melbourne
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Peter MacCallum Cancer Ctr /ID# 256880 - Melbourne
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Epworth Healthcare /ID# 243734 - Richmond
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Recruitment hospital [7]
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Fiona Stanley Hospital /ID# 244753 - Murdoch
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2298 - Waratah
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3065 - Fitzroy Melbourne
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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3121 - Richmond
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Arkansas
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Baden-Wuerttemberg
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Germany
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Essen
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Germany
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Chiba
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Hokkaido
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Ishikawa
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
TeneoOne Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide. Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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Trial website
https://clinicaltrials.gov/study/NCT05259839
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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TeneoOne Inc
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Address
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TeneoOne Inc.
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Contact person for public queries
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ABBVIE CALL CENTER
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Phone
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844-663-3742
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05259839