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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06953960
Registration number
NCT06953960
Ethics application status
Date submitted
17/04/2025
Date registered
1/05/2025
Date last updated
16/09/2025
Titles & IDs
Public title
A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
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Scientific title
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor ABBV-453 Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma
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Secondary ID [1]
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2024-517140-65
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Secondary ID [2]
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M25-275
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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
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-453
Treatment: Drugs - Daratumumab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Pomalidomide
Experimental: Substudy 1: Dose Escalation ABBV-453 Combination - Participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.
Experimental: Substudy 1: Dose Expansion and Selection ABBV-453 Combination - Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.
Active comparator: Substudy 1: Dose Expansion and Selection Control - Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration.
Experimental: Substudy 2: Dose Escalation ABBV-453 Monotherapy - Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.
Treatment: Drugs: ABBV-453
Oral Tablet
Treatment: Drugs: Daratumumab
Subcutaneous (SC) Injection
Treatment: Drugs: Dexamethasone
Oral Tablet
Treatment: Drugs: Pomalidomide
Oral Capsule
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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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Dose-Limiting Toxicities (DLT)s of ABBV-453
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Assessment method [1]
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DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.
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Timepoint [1]
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Up to Approximately 45 Months
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Primary outcome [2]
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Number of Participants with Adverse Events (AE)s
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Assessment method [2]
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An adverse event 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.
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Timepoint [2]
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Up to Approximately 4.5 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 the percentage of participants with a confirmed partial response (PR), very good partial response, complete response (CR) or stringent complete response (sCR) per Investigator review according to International Myeloma Working Group (IMWG) 2016 criteria.
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Timepoint [1]
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Up to Approximately 4.5 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 time from first study treatment to the earliest documented disease progression according to IMWG 2016 criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
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Timepoint [2]
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Up to Approximately 4.5 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 is defined as the time from the date of achieving the first confirmed sCR/CR/VGPR/PR to the date of recurrence disease progression according to IMWG 2016 criteria, as determined by the investigator, or death of any cause, whichever occurs earlier.
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Timepoint [3]
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Up to Approximately 4.5 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 will be 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 4.5 Years
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Secondary outcome [5]
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Time to Next Treatment
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Assessment method [5]
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Time to next treatment will be defined as the number of days from the date of first dose to the date of next treatment.
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Timepoint [5]
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Up to Approximately 4.5 Years
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Secondary outcome [6]
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Minimal Residual Disease (MRD) Negativity
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Assessment method [6]
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MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate per 10\^5 nucleated cells and rate of MRD negativity will be determined.
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Timepoint [6]
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Up to Approximately 4.5 Years
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS is defined as time from first study treatment to death due to any cause.
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Timepoint [7]
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Up to Approximately 4.5 Years
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Eligibility
Key inclusion criteria
* Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.
* All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
* Serum M-protein >= 0.5 g/dL (>= 5g/L); OR
* Urine M-protein >= 200 mg/24 hours; OR
* For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) = 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.
* B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
* t(11;14) positive status and/or BCL2 high status.
* Substudy 1 Dose Escalation Cohorts and Substudy 2:
-- Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment options as deemed by the investigator.
* Substudy 1 Dose Expansion Cohorts:
* Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.
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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
* Major surgery within 4 weeks of study treatment or planned during study participation.
* Active infections: no recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled systemic infection.
* Recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.
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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
Other
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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
23/07/2025
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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
1/12/2030
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Actual
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Sample size
Target
130
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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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Liverpool Hospital /ID# 272002 - Liverpool
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Recruitment hospital [2]
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Calvary Mater Newcastle /ID# 272498 - Waratah
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Recruitment hospital [3]
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St Vincent's Hospital - Melbourne /ID# 271997 - Fitzroy
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Recruitment hospital [4]
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Epworth Hospital /ID# 272497 - Richmond
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Recruitment postcode(s) [1]
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2170 - Liverpool
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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
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Recruitment postcode(s) [4]
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3121 - Richmond
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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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Washington
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Country [2]
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Israel
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State/province [2]
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Tel Aviv
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Country [3]
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Israel
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State/province [3]
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Haifa
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Country [4]
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Israel
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State/province [4]
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Jerusalem
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Country [5]
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Israel
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State/province [5]
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Petah Tikva
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Country [6]
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Japan
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State/province [6]
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Aichi-ken
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Country [7]
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Japan
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State/province [7]
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Kyoto
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Country [8]
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Japan
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State/province [8]
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Osaka
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Country [9]
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Japan
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State/province [9]
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Tokyo
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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 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 change in disease activity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase). In Substudy 2, there will be a dose escalation phase where participants will receive various doses of ABBV-453 alone. Approximately 130 adult participants with R/R MM will be enrolled in the study in approximately 40 sites worldwide. In Substudy 1 escalation phase, participants will receive oral ABBV-453 tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral ABBV-453 tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral ABBV-453 tablets. The total study duration is approximately 4.5 years. 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. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
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Trial website
https://clinicaltrials.gov/study/NCT06953960
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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
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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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)?
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)
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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/NCT06953960
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