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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05308654




Registration number
NCT05308654
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022

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
Scientific title
First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2022-501685-22-01
Secondary ID [2] 0 0
M21-406
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) Criteria
Timepoint [1] 0 0
Up to Approximately 12 Months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to Approximately 24 Months
Secondary outcome [2] 0 0
Depth of Response Minimal Residual Disease (MRD)
Timepoint [2] 0 0
Up to Approximately 24 Months
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
Up to Approximately 36 Months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to Approximately 36 Months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/08/2026
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital /ID# 244826 - Liverpool
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne /ID# 244827 - Fitzroy Melbourne
Recruitment hospital [3] 0 0
St. Vincent's Private Hospital Melbourne /ID# 262631 - Fitzroy
Recruitment hospital [4] 0 0
Austin Health and Ludwig Institute for Cancer Research /ID# 248311 - Heidelberg
Recruitment hospital [5] 0 0
Epworth Healthcare /ID# 248705 - Richmond
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
Israel
State/province [11] 0 0
Tel-Aviv
Country [12] 0 0
Israel
State/province [12] 0 0
Yerushalayim
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05308654