Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04178902
Registration number
NCT04178902
Ethics application status
Date submitted
25/11/2019
Date registered
26/11/2019
Date last updated
26/07/2021
Titles & IDs
Public title
A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma
Query!
Scientific title
A First In Human Study of the MCL-1 Inhibitor, ABBV-467
Query!
Secondary ID [1]
0
0
2018-003744-24
Query!
Secondary ID [2]
0
0
M19-025
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma (MM)
0
0
Query!
Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-467
Experimental: Part A: ABBV-467 Dose Escalation - ABBV-467 administered by intravenous (IV) infusion at various doses until a recommended phase 2 dose is determined.
Experimental: Part B: ABBV-467 Dose Expansion - ABBV-467 administered by intravenous (IV) infusion at recommended phase 2 dose as identified in Part A.
Treatment: Drugs: ABBV-467
Intravenous (IV) Infusion
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants with Adverse Events
Query!
Assessment method [1]
0
0
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator will assess the relationship of each event to the use of study drug as being of reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Query!
Timepoint [1]
0
0
Up to approximately 24 months after first dose of study drug
Query!
Primary outcome [2]
0
0
Change in Vital Signs
Query!
Assessment method [2]
0
0
Change in vital signs like systolic and diastolic blood pressure will be assessed.
Query!
Timepoint [2]
0
0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Query!
Primary outcome [3]
0
0
Change in Electrocardiogram (ECG)
Query!
Assessment method [3]
0
0
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Query!
Timepoint [3]
0
0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Query!
Primary outcome [4]
0
0
Change in Cardiac Enzyme Levels
Query!
Assessment method [4]
0
0
Change in cardiac enzyme levels will be recorded.
Query!
Timepoint [4]
0
0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Query!
Primary outcome [5]
0
0
Incidence of Abnormal Clinical Laboratory Test Results
Query!
Assessment method [5]
0
0
Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
Query!
Timepoint [5]
0
0
Baseline (Week 0) through approximately 24 months after first dose of study drug
Query!
Primary outcome [6]
0
0
Maximum Observed Plasma Concentration (Cmax)
Query!
Assessment method [6]
0
0
Maximum Plasma Concentration (Cmax) of ABBV-467.
Query!
Timepoint [6]
0
0
Up to approximately Day 197
Query!
Primary outcome [7]
0
0
Terminal Phase Elimination Half-life (t1/2)
Query!
Assessment method [7]
0
0
Terminal phase elimination half-life (t1/2) of ABBV-467
Query!
Timepoint [7]
0
0
Up to approximately Day 197
Query!
Primary outcome [8]
0
0
Area Under the Plasma Concentration-Time Curve (AUCt)
Query!
Assessment method [8]
0
0
AUC from time 0 to time of last measurable concentration of ABBV-467.
Query!
Timepoint [8]
0
0
Up to approximately Day 197
Query!
Primary outcome [9]
0
0
Area Under the Plasma Concentration-Time Curve (AUC0-infinity)
Query!
Assessment method [9]
0
0
AUC from time 0 to infinity of ABBV-467.
Query!
Timepoint [9]
0
0
Up to approximately Day 197
Query!
Primary outcome [10]
0
0
Clearance of ABBV-467
Query!
Assessment method [10]
0
0
Clearance of ABBV-467.
Query!
Timepoint [10]
0
0
Up to approximately Day 197
Query!
Secondary outcome [1]
0
0
Overall Response Rate (ORR)
Query!
Assessment method [1]
0
0
ORR evaluated per adapted International Myeloma Working Group (IMWG) criteria and defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR).
Query!
Timepoint [1]
0
0
Up to approximately 24 months after first dose of study drug
Query!
Secondary outcome [2]
0
0
Clinical Benefit Rate (CBR)
Query!
Assessment method [2]
0
0
CBR evaluated per adapted International Myeloma Working Group (IMWG) criteria and is defined as minimal response (MR) + PR + VGPR + CR + sCR.
Query!
Timepoint [2]
0
0
Up to approximately 24 months after first dose of study drug
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR)
Query!
Assessment method [3]
0
0
DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever comes first.
Query!
Timepoint [3]
0
0
Up to approximately 24 months after first dose of study drug
Query!
Eligibility
Key inclusion criteria
- Documented diagnosis of multiple myeloma (MM).
- Measurable disease defined as at least 1 of the following:
- Serum monoclonal protein >= 1g/dL.
- Urine M-protein >= 200mg/24 hours.
- Serum immunoglobulin free light chain (FLC) >= 10 mg/dL (100 mg/L), provided
serum FLC ratio is abnormal.
- Relapsed after or are refractory or intolerant to all established MM therapies that
are both known to provide clinical benefit and locally available.
- Received at least 3 prior lines of therapy including 1 or more immunomodulatory
agents, 1 or more proteasome inhibitors, and 1 or more anti-CD38 monoclonal
antibodies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate hematologic, renal and hepatic function as described in the protocol.
- Echocardiogram with ejection fraction >= 50% and no other clinically significant
findings that would increase the participant's susceptibility to cardiac toxicity.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Prior exposure to any targeted myeloid cell leukemia-1 (MCL-1) inhibitor.
- Antineoplastic therapy (including any cytotoxic, targeted and/or investigational
therapy; but not including corticosteroids), within 28 days or 5 half-lives, whichever
is shorter, prior to the first dose of study drug and through the last dose of study
drug.
- Autologous stem cell transplant within 90 days prior to start of study drug.
- Allogenic stem cell transplant within 180 days prior to start of study drug.
- History of acute or chronic pancreatitis.
- Significant unresolved liver disease.
- History of hepatitis B or human immunodeficiency virus (HIV) infection.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/05/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/04/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
8
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Royal Adelaide Hospital /ID# 223354 - Adelaide
Query!
Recruitment hospital [2]
0
0
St Vincent's Hospital Melbourne /ID# 222066 - Fitzroy
Query!
Recruitment hospital [3]
0
0
Alfred Health /ID# 214665 - Melbourne
Query!
Recruitment hospital [4]
0
0
Perth Blood Institute Ltd /ID# 226650 - Nedlands
Query!
Recruitment hospital [5]
0
0
Royal Perth Hospital /ID# 225498 - Perth
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [5]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
New Jersey
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Rhode Island
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
South Carolina
Query!
Country [6]
0
0
France
Query!
State/province [6]
0
0
Pays-de-la-Loire
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Creteil
Query!
Country [8]
0
0
Israel
Query!
State/province [8]
0
0
Tel-Aviv
Query!
Country [9]
0
0
Japan
Query!
State/province [9]
0
0
Aichi
Query!
Country [10]
0
0
Japan
Query!
State/province [10]
0
0
Chiba
Query!
Country [11]
0
0
Japan
Query!
State/province [11]
0
0
Fukuoka
Query!
Country [12]
0
0
Japan
Query!
State/province [12]
0
0
Tokyo
Query!
Country [13]
0
0
Spain
Query!
State/province [13]
0
0
Navarra, Comunidad
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
Barcelona
Query!
Country [15]
0
0
Spain
Query!
State/province [15]
0
0
Madrid
Query!
Country [16]
0
0
Spain
Query!
State/province [16]
0
0
Malaga
Query!
Country [17]
0
0
Taiwan
Query!
State/province [17]
0
0
Taipei
Query!
Country [18]
0
0
Taiwan
Query!
State/province [18]
0
0
Taichung City
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult
participants with relapsed/refractory multiple myeloma (MM).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04178902
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04178902
Download to PDF