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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05308654
Registration number
NCT05308654
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022
Date last updated
25/01/2024
Titles & IDs
Public title
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
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Scientific title
First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma
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Secondary ID [1]
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2022-501685-22-01
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Secondary ID [2]
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M21-406
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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-453
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab
Treatment: Drugs - Lenalidomide
Experimental: Part 1: Monotherapy Dose Escalation - Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined.
Experimental: Part 2: Arm 1 - Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles.
Experimental: Part 2: Arm 2 - Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles.
Experimental: Part 2: Arm 3 - Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles.
Experimental: Japan Cohort - Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined.
Treatment: Drugs: ABBV-453
Oral; Tablet
Treatment: Drugs: Dexamethasone
Oral Tablet
Treatment: Drugs: Daratumumab
Subcutaneous Injection
Treatment: Drugs: Lenalidomide
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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Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) Criteria
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Assessment method [1]
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ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).
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Timepoint [1]
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Up to Approximately 12 Months
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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DOR is defined for participants achieving a confirmed sCR/CR/VGPR/PR as the time from the initial response of sCR/CR/VGPR/PR per investigator review according to adapted IMWG criteria to disease progression or death of any cause, whichever occurs earlier.
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Timepoint [1]
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Up to Approximately 24 Months
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Secondary outcome [2]
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Depth of Response Minimal Residual Disease (MRD)
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Assessment method [2]
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MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate. Depth of response is defined as the proportion of MRD negativity for participants achieving a confirmed sCR/CR per investigator review according to IMWG criteria.
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Timepoint [2]
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Up to Approximately 24 Months
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Secondary outcome [3]
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Progression Free Survival (PFS)
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Assessment method [3]
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PFS is defined as time from first study treatment to a documented disease progression according to adapted IMWG criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.
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Timepoint [3]
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Up to Approximately 36 Months
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Overall survival (OS) is defined as time from first study treatment to death due to any cause.
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Timepoint [4]
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Up to Approximately 36 Months
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Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status <= 1.
- Laboratory values meeting the criteria outlined in the protocol.
- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma
Working Group (IMWG) criteria.
- Has measurable disease at screening as defined in the protocol.
- Locally documented or centrally determined t(11;14) positive status and/or centrally
determined BCL2high status. Note: If local testing for t(11;14) is discordant with
central testing for t(11;14) status, a detailed review of central and local results
for t(11;14) status is required to ensure the participants' safety.
- Part 1 and Part 2, Arm 1 Only: Refractory to or intolerant of all established MM
therapies that are known to provide clinical benefit and are triple class exposed to a
proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38
monoclonal antibody in previous line(s) of therapy.
- Part 2, Arms 2 and 3 Only: Received 1 to 3 prior lines of therapy, including a PI or
an IMiD.
- Part 1 only: Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines
of therapy.
- Life expectancy >= 12 weeks.
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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 relevant or significant Electrocardiogram (ECG) abnormalities as outlined
in the protocol.
- Part 2 only: Previous treatment with venetoclax or BCL-2 inhibitor.
- Part 2, Arms 2 and 3 only: Prior daratumumab or other anti-CD38 therapy exposure that
meets any of the criteria outlined in the protocol.
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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
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
17/05/2022
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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
28/08/2026
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Actual
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Sample size
Target
360
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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# 244826 - Liverpool
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Recruitment hospital [2]
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St Vincent's Hospital Melbourne /ID# 244827 - Fitzroy Melbourne
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Recruitment hospital [3]
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St. Vincent's Private Hospital Melbourne /ID# 262631 - Fitzroy
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Recruitment hospital [4]
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Austin Health and Ludwig Institute for Cancer Research /ID# 248311 - Heidelberg
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Recruitment hospital [5]
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Epworth Healthcare /ID# 248705 - 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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3065 - Fitzroy Melbourne
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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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3084 - Heidelberg
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Recruitment postcode(s) [5]
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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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California
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United States of America
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Florida
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United States of America
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State/province [3]
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Louisiana
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Michigan
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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New York
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Country [8]
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United States of America
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State/province [8]
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Israel
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Tel-Aviv
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Country [12]
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Israel
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State/province [12]
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Yerushalayim
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Country [13]
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United Kingdom
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State/province [13]
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London, City Of
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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 toxicity 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. Part 1 will
be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2,
participants are placed in 1 of 3 groups called treatment arms. Each group receives a
different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult
participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites
worldwide.
In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily
(QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral
ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day
cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets
QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral
dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will
receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous
injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and
oral dexamethasone tablets once weekly, 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, and side effects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05308654
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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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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05308654
Download to PDF