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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05259839




Registration number
NCT05259839
Ethics application status
Date submitted
18/02/2022
Date registered
2/03/2022

Titles & IDs
Public title
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
2023-506871-88-00
Secondary ID [2] 0 0
M22-947
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 - Etentamig
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Daratumumab

Experimental: Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone) - Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.

Experimental: Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.

Experimental: Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.

Experimental: Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.


Treatment: Drugs: Etentamig
Intravenous (IV) Infusion

Treatment: Drugs: Dexamethasone
Oral; Tablet or IV Infusion

Treatment: Drugs: Lenalidomide
Oral; Capsule

Treatment: Drugs: Pomalidomide
Oral; Capsule

Treatment: Drugs: Daratumumab
Subcutaneous Injection (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig
Timepoint [1] 0 0
Up to approximately 28 Days
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to Approximately 3 Years
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to Approximately 3 Years
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Up to Approximately 3 Years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to Approximately 3 Years
Secondary outcome [4] 0 0
Time-to-Progression (TTP)
Timepoint [4] 0 0
Up to Approximately 3 Years
Secondary outcome [5] 0 0
Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)
Timepoint [5] 0 0
Up to Approximately 3 Years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
* Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
* Must have measurable disease as determined by central lab as outlined in the protocol.
* Must be naïve to treatment with Etentamig.
* Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
* Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
* Arm E: Participant has received 1-3 prior lines of MM treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
* Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
* Has any of the following conditions:

* Nonsecretory Multiple Myeloma (MM).
* Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
* Waldenstrom's macroglobulinemia.
* Light chain amyloidosis.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
* Major surgery within 4 weeks prior to first dose or planned study participation.
* Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
* Uncontrolled diabetes or hypertension within 14 days prior to first dose.
* Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.

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
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
20/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2033
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital /ID# 243740 - Kogarah
Recruitment hospital [2] 0 0
Calvary Mater Newcastle /ID# 243730 - Waratah
Recruitment hospital [3] 0 0
Monash Health - Monash Medical Centre /ID# 244403 - Clayton
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne /ID# 256879 - Fitzroy Melbourne
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Ctr /ID# 256880 - Melbourne
Recruitment hospital [6] 0 0
Epworth Healthcare /ID# 243734 - Richmond
Recruitment hospital [7] 0 0
Fiona Stanley Hospital /ID# 244753 - Murdoch
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3121 - Richmond
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
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
New Jersey
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
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Germany
State/province [13] 0 0
Baden-Wuerttemberg
Country [14] 0 0
Germany
State/province [14] 0 0
Bayern
Country [15] 0 0
Germany
State/province [15] 0 0
Essen
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Regensburg
Country [18] 0 0
Italy
State/province [18] 0 0
Emilia-Romagna
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Reggio Emilia
Country [21] 0 0
Italy
State/province [21] 0 0
Roma
Country [22] 0 0
Japan
State/province [22] 0 0
Aichi
Country [23] 0 0
Japan
State/province [23] 0 0
Chiba
Country [24] 0 0
Japan
State/province [24] 0 0
Hokkaido
Country [25] 0 0
Japan
State/province [25] 0 0
Ishikawa
Country [26] 0 0
Japan
State/province [26] 0 0
Okayama
Country [27] 0 0
Japan
State/province [27] 0 0
Yamagata
Country [28] 0 0
Poland
State/province [28] 0 0
Dolnoslaskie
Country [29] 0 0
Poland
State/province [29] 0 0
Lubelskie
Country [30] 0 0
Poland
State/province [30] 0 0
Pomorskie
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Navarra
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TeneoOne Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
TeneoOne Inc
Address 0 0
TeneoOne Inc.
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


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/NCT05259839