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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06158841
Registration number
NCT06158841
Ethics application status
Date submitted
28/11/2023
Date registered
6/12/2023
Titles & IDs
Public title
Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
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Scientific title
A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
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Secondary ID [1]
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2023-506668-15-00
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Secondary ID [2]
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M22-574
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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:
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 - Carfilzomib
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Selinexor
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Experimental: ABBV-383 - Participants will receive ABBV-383 as a monotherapy.
Experimental: Standard Available Therapy (SAT) - Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab + pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).
Treatment: Drugs: ABBV-383
Intravenous (IV) Infusion
Treatment: Drugs: Carfilzomib
IV Infusion
Treatment: Drugs: Pomalidomide
Oral Capsule
Treatment: Drugs: Elotuzumab
IV Infusion
Treatment: Drugs: Selinexor
Oral Tablet
Treatment: Drugs: Bortezomib
Subcutaneous or IV Injection
Treatment: Drugs: Dexamethasone
Oral Tablet or IV Infusion
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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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Progression Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.
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Timepoint [1]
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Up to Approximately 5 Years
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Primary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.
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Timepoint [2]
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Up to Approximately 5 Years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the duration from the date of randomization to the date of the participant's death.
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Timepoint [1]
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Up to Approximately 5 Years
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Secondary outcome [2]
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Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)
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Assessment method [2]
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The rate of \>= VGPR is defined as the proportion of participants who achieve a VGPR or better determined by IMWG (2016) response criteria, per IRC assessment, prior to the initiation of new myeloma therapy.
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Timepoint [2]
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Up to Approximately 5 Years
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Secondary outcome [3]
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Change in Rate of CR or Better (>=CR)
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Assessment method [3]
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\>=CR is defined as the percentage of participants who achieve confirmed CR + sCR or per IRC assessment.
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Timepoint [3]
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Up to Approximately 5 Years
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Secondary outcome [4]
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Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR
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Assessment method [4]
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MRD negativity with \>= CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by next-generation sequencing (NGS) Adaptive Clonoseq at 10\^-5 threshold.
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Timepoint [4]
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Up to Approximately 5 Years
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Secondary outcome [5]
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Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)
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Assessment method [5]
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The disease symptoms domain of EORTC QLQ-MY20 is a 6-item questionnaire to assess the physical function of the participant, with a higher score indicating a higher level of symptoms.
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Timepoint [5]
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0
Up to 6 Months
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Secondary outcome [6]
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Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
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Assessment method [6]
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The physical functioning domain of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indicating worse functioning.
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Timepoint [6]
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0
Up to 6 Months
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Secondary outcome [7]
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Time to Response (TTR)
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Assessment method [7]
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TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria as assessed by IRC.
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Timepoint [7]
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Up to Approximately 5 Years
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Secondary outcome [8]
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Duration of Response (DOR)
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Assessment method [8]
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DOR is defined as the number of days from the day the response criteria are met to the date that disease progression as determined by the IRC.
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Timepoint [8]
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Up to Approximately 5 Years
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Secondary outcome [9]
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Time-to-Progression (TTP)
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Assessment method [9]
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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 as determined by the IRC.
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Timepoint [9]
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Up to Approximately 5 Years
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Secondary outcome [10]
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Time to Next Anti-lymphoma Therapy (TTNT)
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Assessment method [10]
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TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
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Timepoint [10]
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Up to Approximately 5 Years
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Secondary outcome [11]
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Number of Participants with Event-free Survival (EFS)
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Assessment method [11]
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EFS is defined as the time from randomization until adverse event determined by the IRC, or death, whichever occurs first.
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Timepoint [11]
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Up to Approximately 5 Years
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Secondary outcome [12]
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Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)
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Assessment method [12]
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The PROMIS Fatigue SF7a is a 7-item short form that assesses the impact and experience of fatigue in the past 7 days. For each item, 5-point rating scales are used to measure frequency ("Never," "Rarely," "Sometimes," "Often," or "Always") with a higher score indicating a greater impact.
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Timepoint [12]
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0
Up to Approximately 6 Months
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Secondary outcome [13]
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Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [13]
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The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items are scored from 0 to 4 to evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.
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Timepoint [13]
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Up to Approximately 6 Months
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Secondary outcome [14]
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Change from Baseline in Remaining Items in the EORTC QLQ-C30
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Assessment method [14]
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The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.
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Timepoint [14]
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Up to Approximately 6 Months
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Secondary outcome [15]
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Change from Baseline in Remaining Items in the EORTC QLQ-MY20
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Assessment method [15]
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The EORTC QLQ-MY20 consists of four scales: two symptom scales (Disease Symptoms \[6 items\] and Side Effects of Treatment \[10 items\]), one function scale (Future Perspective \[3 items\]), and one single item (Body Image). Each item has four response options: "Not at all," "A little," "Quite a bit," or "Very much". All scores are then linearly transformed to a 0 to 100 scale. A higher score on the symptom scales indicates a higher level of symptoms, whereas higher scores on future perspective and body image indicate good functioning or support.
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Timepoint [15]
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Up to Approximately 6 Months
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Secondary outcome [16]
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Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)
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Assessment method [16]
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The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.
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Timepoint [16]
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Up to Approximately 6 Months
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Secondary outcome [17]
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Change from Baseline in Patient Global Impression of Severity (PGIS)
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Assessment method [17]
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The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.
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Timepoint [17]
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Up to Approximately 6 Months
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Secondary outcome [18]
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Change from Baseline in Patient Global Impression of Change (PGIC)
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Assessment method [18]
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The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
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Timepoint [18]
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Up to Approximately 6 Months
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Secondary outcome [19]
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Number of Participants with Skeletal-Related Event (SRE)
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Assessment method [19]
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SREs are defined as the presence of any of the following spinal cord compression, pathologic fracture, surgery to bone, or radiation to bone.
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Timepoint [19]
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Up to Approximately 5 Years
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
* Serum M-protein >= 0.5 g/dL (>= 5 g/L).
* Urine M-protein >= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be naïve to treatment with B-cell maturation antigen (BCMA)-targeted therapy.
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
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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
* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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 3
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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
19/05/2024
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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
25/01/2028
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Actual
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Sample size
Target
380
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St George Hospital /ID# 261806 - Kogarah
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Recruitment hospital [2]
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Calvary Mater Newcastle /ID# 261804 - Waratah
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Recruitment hospital [3]
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St Vincent's Hospital Melbourne /ID# 261808 - Fitzroy Melbourne
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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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3065 - Fitzroy Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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0
United States of America
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State/province [2]
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Maryland
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
0
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Austria
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State/province [4]
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Oberoesterreich
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Country [5]
0
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Austria
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State/province [5]
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Steiermark
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Country [6]
0
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China
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State/province [6]
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Beijing
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Country [7]
0
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France
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State/province [7]
0
0
Sarthe
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Country [8]
0
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France
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State/province [8]
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Vaucluse
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Country [9]
0
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France
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State/province [9]
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Orléans
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Country [10]
0
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Greece
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State/province [10]
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Attiki
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Country [11]
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Greece
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State/province [11]
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Athens
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Country [12]
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Greece
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State/province [12]
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Thessaloniki
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Country [13]
0
0
Israel
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State/province [13]
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Tel-Aviv
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Country [14]
0
0
Israel
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State/province [14]
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Yerushalayim
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Country [15]
0
0
Israel
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State/province [15]
0
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Haifa
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Country [16]
0
0
Japan
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State/province [16]
0
0
Chiba
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Country [17]
0
0
Japan
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State/province [17]
0
0
Gifu
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Country [18]
0
0
Japan
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State/province [18]
0
0
Hiroshima
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Country [19]
0
0
Japan
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State/province [19]
0
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Miyagi
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Country [20]
0
0
Japan
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State/province [20]
0
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Osaka
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Country [21]
0
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Japan
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State/province [21]
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0
Amagasaki
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Country [22]
0
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Korea, Republic of
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State/province [22]
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Seoul Teugbyeolsi
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Country [23]
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Korea, Republic of
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State/province [23]
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Ulsan Gwang Yeogsi
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Country [24]
0
0
Korea, Republic of
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State/province [24]
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Seoul
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Country [25]
0
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Portugal
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State/province [25]
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Regiao Autonoma Da Madeira
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Country [26]
0
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South Africa
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State/province [26]
0
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Gauteng
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Country [27]
0
0
South Africa
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State/province [27]
0
0
Western Cape
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Country [28]
0
0
Spain
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State/province [28]
0
0
Ourense
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Country [29]
0
0
Spain
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State/province [29]
0
0
Leon
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Country [30]
0
0
Spain
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State/province [30]
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Madrid
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Country [31]
0
0
Spain
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State/province [31]
0
0
Salamanca
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Country [32]
0
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Spain
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State/province [32]
0
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Valencia
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Country [33]
0
0
Sweden
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State/province [33]
0
0
Falun
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Country [34]
0
0
Taiwan
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State/province [34]
0
0
Keelung
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Country [35]
0
0
Taiwan
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State/province [35]
0
0
Taipei
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Country [36]
0
0
Taiwan
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State/province [36]
0
0
Taichung
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. . In Arm A, participants will receive ABBV-383 as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive ABBV-383 as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT06158841
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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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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
0
0
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Country
0
0
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Phone
0
0
844-663-3742
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Fax
0
0
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Email
0
0
[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)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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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/NCT06158841