Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
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
Date last updated
7/06/2024

Titles & IDs
Public title
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused 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 ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
2021-005587-22
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 - ABBV-383
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Nirogacestat
Treatment: Drugs - Daratumumab

Experimental: Arm A (ABBV-383 with Pomalidomide and Dexamethasone) - Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.

Experimental: Arm B (ABBV-383 with Lenalidomide and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.

Experimental: Arm C (ABBV-383 with Daratumumab and Dexamethasone) - Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.

Experimental: Arm D (ABBV-383 with Nirogacestat) - Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.


Treatment: Drugs: ABBV-383
Intravenous (IV) Infusion

Treatment: Drugs: Dexamethasone
Oral; Tablet or IV Infusion

Treatment: Drugs: Lenalidomide
Oral; Capsule

Treatment: Drugs: Pomalidomide
Oral; Capsule

Treatment: Drugs: Nirogacestat
Oral; Tablet

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 ABBV-383
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 Disease Negativity (MRD)
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 outlined in the protocol.
* Must be naïve to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
* Has received prior MM treatment in Arms A, B, C, and D.
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 drug 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.
* Known central nervous system involvement Multiple Myeloma (MM).
* Has any of the following conditions:

* Nonsecretory 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 drug 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.
* Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

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
21/07/2031
Actual
Sample size
Target
270
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 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
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Hamburg
Country [16] 0 0
Germany
State/province [16] 0 0
Regensburg
Country [17] 0 0
Germany
State/province [17] 0 0
Wuerzburg
Country [18] 0 0
Italy
State/province [18] 0 0
Lazio
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Bologna
Country [21] 0 0
Italy
State/province [21] 0 0
Meldola
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Japan
State/province [23] 0 0
Aichi
Country [24] 0 0
Japan
State/province [24] 0 0
Chiba
Country [25] 0 0
Japan
State/province [25] 0 0
Hokkaido
Country [26] 0 0
Japan
State/province [26] 0 0
Ishikawa
Country [27] 0 0
Japan
State/province [27] 0 0
Okayama
Country [28] 0 0
Japan
State/province [28] 0 0
Yamagata
Country [29] 0 0
Poland
State/province [29] 0 0
Dolnoslaskie
Country [30] 0 0
Poland
State/province [30] 0 0
Lubelskie
Country [31] 0 0
Poland
State/province [31] 0 0
Pomorskie
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Navarra
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla

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

Ethics approval
Ethics application status

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-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed.

ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide.

Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro 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, questionnaires and side effects.
Trial website
https://clinicaltrials.gov/study/NCT05259839
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05259839