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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04973605




Registration number
NCT04973605
Ethics application status
Date submitted
7/07/2021
Date registered
22/07/2021

Titles & IDs
Public title
A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib in Multiple Myeloma
Scientific title
A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone and Carfilzomib/Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)
Secondary ID [1] 0 0
2021-003614-39
Secondary ID [2] 0 0
BGB-11417-105
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 - BGB-11417
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Carfilzomib

Experimental: Part 1 Dose Escalation - Dose-escalation and de-escalation to determine maximum tolerated dose (MTD)

Experimental: Part 2 Cohort Expansion - There will be 5 expansion cohorts to further evaluate the safety and efficacy of BGB-11417


Treatment: Drugs: BGB-11417
Administered orally daily

Treatment: Drugs: Dexamethasone
Once weekly either orally or intravenously

Treatment: Drugs: Carfilzomib
Administered intravenously weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timepoint [1] 0 0
Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
Primary outcome [2] 0 0
Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5
Timepoint [2] 0 0
Up to 24 months after last dose of study drug
Primary outcome [3] 0 0
Part 2: Overall response rate (ORR)
Timepoint [3] 0 0
Approximately 4 years
Primary outcome [4] 0 0
Part 2: Very good partial response (VGPR) or better response rate
Timepoint [4] 0 0
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]
Primary outcome [5] 0 0
Part 2: Complete Response (CR) or better
Timepoint [5] 0 0
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary outcome [1] 0 0
Part 1: Area under the plasma concentration-time curve (AUC)
Timepoint [1] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [2] 0 0
Part 1: Maximum observed plasma concentration (Cmax)
Timepoint [2] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [3] 0 0
Part 1: Time to reach Cmax (tmax)
Timepoint [3] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [4] 0 0
Part 1: After steady-state: AUC last,ss
Timepoint [4] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [5] 0 0
Part 1: After steady-state: Cmax, ss
Timepoint [5] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [6] 0 0
Part 1: After steady-state: trough plasma concentration (Ctrough) ss
Timepoint [6] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [7] 0 0
Part 1: After steady-state: time to reach Cmax (tmax,ss)
Timepoint [7] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Secondary outcome [8] 0 0
Part 2: Time to response (TTR) as assessed by investigator
Timepoint [8] 0 0
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary outcome [9] 0 0
Part 2: Duration of response (DOR) as assessed by investigator
Timepoint [9] 0 0
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary outcome [10] 0 0
Part 2: Progression-free survival (PFS) as assessed by investigator
Timepoint [10] 0 0
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years])
Secondary outcome [11] 0 0
Part 2: Overall survival (OS) as assessed by investigator
Timepoint [11] 0 0
Upon study termination (Baseline up to approximately 4 years)

Eligibility
Key inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
3. Measurable disease defined as:

i. M-spike = 500mg/dL, or ii. Urine protein M-spike of = 200 mg/day, or iii. Serum free light chains = 10 mg/dL, and an abnormal ?:? ratio
4. Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.

i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.

ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
1. Participants in Part 1 should have failed all other available options including having had = 3 prior lines of therapy including a proteasome inhibitor, IMiD agent, and an anti-CD38 monoclonal antibody.
2. Participants in Part 2 should have had and failed = 1 but = 7 prior lines of therapy and will have had prior treatment with both a proteasome inhibitor and an IMiD agent.

Note: A line of therapy consists of greater = 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens. Induction therapy with consolidation and maintenance following stem cell transplant is considered a single line of therapy.
3. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory and not have had carfilzomib within the past 6 months
5. Positivity for t(11;14) by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory

a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
6. Adequate organ function defined as:

1. Hemoglobin = 8.0 g/dL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
2. Platelet count = 75,000/µL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
3. Absolute neutrophil count (ANC) = 1000/mm3 [ANC = (% of segmented neutrophils + % of segmented bands) x total WBC count within 7 days before first dose of study treatment
4. ALT and AST = 3 x upper limit of normal (ULN) and total bilirubin = 2.0 x ULN Serum creatinine = 1.5 x ULN or creatinine clearance = 45 mL/min/1.73 m2 calculated by the MDRD-6 formula.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has any of the following conditions:

1. Non secretory MM (Serum free light chains < 10 mg/dL)
2. Solitary plasmacytoma
3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)
4. Waldenström macroglobulinemia
5. Amyloidosis.
6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
7. Uncontrolled diabetes (HbA1c > 7% or 53 mmol/mol or requiring insulin at study entry
8. Chronic respiratory disease that requires continuous oxygen
2. Significant cardiovascular disease, including but not limited to:

1. Myocardial infarction = 6 months before screening
2. Ejection fraction = 50%
3. Unstable angina= 3 months before screening
4. New York Heart Association Class III or IV congestive heart failure
5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
6. Heart rate-corrected QT interval > 480 milliseconds based on Fridericia's formula
7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
8. Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by = 2 consecutive measurements
3. Known infection with human immunodeficiency virus (HIV)
4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:

1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.
2. Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
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
16/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
167
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Brazil
State/province [14] 0 0
Brasilia
Country [15] 0 0
Brazil
State/province [15] 0 0
Porto Alegre
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Chongqing
Country [23] 0 0
China
State/province [23] 0 0
Fujian
Country [24] 0 0
China
State/province [24] 0 0
Guangdong
Country [25] 0 0
China
State/province [25] 0 0
Hebei
Country [26] 0 0
China
State/province [26] 0 0
Henan
Country [27] 0 0
China
State/province [27] 0 0
Hunan
Country [28] 0 0
China
State/province [28] 0 0
Jiangsu
Country [29] 0 0
China
State/province [29] 0 0
Jiangxi
Country [30] 0 0
China
State/province [30] 0 0
Liaoning
Country [31] 0 0
China
State/province [31] 0 0
Shandong
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Tianjin
Country [34] 0 0
China
State/province [34] 0 0
Zhejiang
Country [35] 0 0
France
State/province [35] 0 0
Lille
Country [36] 0 0
France
State/province [36] 0 0
Nantes Cedex
Country [37] 0 0
France
State/province [37] 0 0
Poitiers
Country [38] 0 0
Germany
State/province [38] 0 0
Aachen
Country [39] 0 0
Germany
State/province [39] 0 0
Dresden
Country [40] 0 0
Germany
State/province [40] 0 0
Hamburg
Country [41] 0 0
Germany
State/province [41] 0 0
Wurzburg
Country [42] 0 0
Greece
State/province [42] 0 0
Alexandroupolis
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Israel
State/province [44] 0 0
Petach Tikva
Country [45] 0 0
Israel
State/province [45] 0 0
Tel Aviv
Country [46] 0 0
Italy
State/province [46] 0 0
Bari
Country [47] 0 0
Italy
State/province [47] 0 0
Bologna
Country [48] 0 0
Italy
State/province [48] 0 0
Meldola
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Torino
Country [52] 0 0
Italy
State/province [52] 0 0
Torrette
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul Teugbyeolsi
Country [54] 0 0
New Zealand
State/province [54] 0 0
Auckland
Country [55] 0 0
Singapore
State/province [55] 0 0
Singapore
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona
Country [57] 0 0
Spain
State/province [57] 0 0
Caceres
Country [58] 0 0
Spain
State/province [58] 0 0
Malaga
Country [59] 0 0
Spain
State/province [59] 0 0
Sevilla
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Headington
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Sutton
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Truro

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04973605